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Biosafety Guidelines For Research On Genetically Modified ...

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APPENDIX 8: REQUIREMENTS FOR GENETIC MODIFICATION BIOSAFETY LEVEL<br />

3 (GM-BSL3)<br />

GM-BSL 3 and 4 facilities must be approved by the relevant regulatory agency before<br />

commencement of work. The requirements for <strong>Biosafety</strong> Level 3 in the Laboratory<br />

<strong>Biosafety</strong> Manual (3 rd Ed, WHO) and the OSH <strong>Guidelines</strong> for Laboratories and<br />

Production Facilities in the Biomedical Sciences Industry shall apply for GM-BSL3.<br />

Essentially, work in laboratories at GM-BSL3 level shall conform with the procedures set<br />

out for GM-BSL2 laboratories, with the following additional requirements:<br />

Laboratory Procedures<br />

1. All aerosol-producing equipment such as that for sonication and vortexing shall be<br />

kept and used in the biosafety cabinet.<br />

2. The biosafety cabinet and/or the laboratory shall be decontaminated with<br />

formaldehyde gas after major spills of contaminated material. Records of such spills<br />

and any other accidents must be kept, detailing date, time and personels involved<br />

with the cleaning up measures taken. Such records must be available for inspection<br />

at all times.<br />

3. No other work is to be done simultaneously with work requiring GM-BSL3<br />

containment.<br />

4. While work is in progress a sign on the door shall indicate the level of containment<br />

required for that work.<br />

5. Protective clothing shall not be worn outside the laboratory; it shall be transported to<br />

the decontamination area in sealed bags or boxes. Boxes shall have provision for<br />

penetration of steam during autoclaving.<br />

6. No one may enter the laboratory for cleaning, servicing of equipment, repairs or<br />

other activities unless the principal investigator or the biosafety officer has been<br />

informed and laboratory surfaces have been disinfected.<br />

7. Where a pressure steam steriliser (autoclave) is not available within the laboratory,<br />

laboratory wastes shall be bagged and placed in an unbreakable container with a<br />

secured lid for transport to the pressure steam steriliser. The surface of the container<br />

should be decontaminated with a suitable disinfectant. Wastes shall not be stored<br />

outside the facility before they are sterilised.<br />

Laboratory Planning and Construction<br />

8. The laboratory shall not be located adjacent to, nor open onto, corridors used by the<br />

general public.<br />

Decontamination<br />

9. Provision shall be made to decontaminate the biological safety cabinet(s) and the<br />

room independently with formaldehyde gas, and for the gas to be purged safely to<br />

atmosphere upon completion of the procedure.<br />

10. Decontamination of the safety cabinet(s) shall be performed in accordance with the<br />

requirements of established International Standards (see Appendix 1) and will<br />

Appendix - Page 17

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