BIOHAZARD RISK ASSESSMENT

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1 BIOHAZARD RISK ASSESSMENT NAME: DATE: TITLE OF ACTIVITY OR PROJECT: BRIEF DESCRIPTION OF THE BIOLOGICAL AND ITS TREATMENT: DURATION OF ACTIVITY OR PROJECT: FACILITY TO BE USED (Campus, Building and Room Number): Note: In determining whether a specimen has a minimal likelihood that pathogens are present, an element of professional judgment is required to determine if a substance is exempt. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. Question Yes No Action Required 1. Does the biological solely consist of: purified or synthesised inert DNA, RNA or protein, which is not being used for gene technology? If Yes no biological hazard or gene technology application required. See Other Approvals 2. Does the biological solely consist of: substances neutralized or inactivated, or bodily fluids dried on absorbent material, or material collected for transfusion or transplantation, which is not being used for gene technology? 3. Does the protocol involve the use of genetically naïve micro-organisms? If Yes no biological hazard or gene technology application required. See Other Approvals If Yes, Refer to Appendix 1 AS/NZS : Section 3 - Degree of Hazard from Microorganisms to determine risk level. 1 The Standard AS/NZS :2010 Part 3: Microbiological safety and containment may be accessed through the SAI Global public database, Standards Online, via the University library. Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 1 of 18

2 Question Yes No Action Required 4. Does the protocol involve the use of untreated material/samples (including but not limited to excretions, blood and its components, tissue and tissue fluid swabs, and body parts) collected directly from genetically naive animals (including invertebrate), plants, soil or other materials? AND There is a reasonable expectation that they may transmit viable micro-organisms or infectious agents to humans, animals or the environment? If Yes, Refer to Appendix 1 AS/NZS :2010 Section 3 - Degree of Hazard from Microorganisms to determine risk level Note: It has been reported that about 30% of laboratory mice are infected with norovirus. Lab.Ani : Does the protocol involve the use of unmodified human tissue or body fluids where there is a reasonable expectation that they may transmit viable micro-organisms or infectious agents to humans, animals or the environment? 6. Does the protocol involve the use of unmodified cell lines where there is a reasonable expectation that they may transmit viable micro-organisms or infectious agents to humans, animals or the environment? 7. Are there any unmodified biologicals involved in this project which are not listed in Appendix 1 - AS/NZS :2010 Section 3 - Degree of Hazard from Micro-organisms 8. Does the protocol involve the use of unmodified biologicals which are Risk Group 2 or greater? If Yes, Refer to Appendix 1 AS/NZS :2010 Section 3 - Degree of Hazard from Microorganisms, to determine risk level of the infectious agent. If Yes, Refer to Appendix 1 AS/NZS :2010 Section 3 - Degree of Hazard from Microorganisms to determine risk level of the infectious agent. If Yes, determine the risk level in your professional judgment in reference to AS/NZS :2010. You are welcome to consult with the Chair of the IBC. If Yes, submit a copy of this risk assessment and a Biological Hazard Application to Biosafety@unisa.edu.au Work must not commence before approval from the Institutional Biosafety Committee is granted. Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 2 of 18

3 Question Yes No Action Required 9. Does your activity or project involve the use of animals (including invertebrates), plants or other organisms where there is a reasonable expectation that they may transmit viable toxins harmful to humans, animals or the environment? 10. Does your activity or project involve the use, transportation or storage of gene technology? Gene technology includes, among other things, cell lines which have been previously genetically modified. Please see Appendix 3 for note on CRISPR/Cas, Talen, ZFN and MNs. If Yes, submit a copy of this risk assessment and a Biological Hazard Application to Biosafety@unisa.edu.au Work must not commence before approval from the Institutional Biosafety Committee is granted. If Yes, submit a copy of this risk assessment and an application for Exempt and Notifiable Low Risk Dealings to Biosafety@unisa.edu.au Work must not commence before approval from the Institutional Biosafety Committee is granted. Other Approvals Question Yes No Action Required 11. Does the activity involve the use of naive whole animals or animal fluids or tissues for which prior ethics approval has not been obtained? Note: processed tissues (such as set in blocks, fixed or onto slides) do not require AEC notification. 12. Does the activity involve the use of naïve human fluids or tissues, other than commercial cell lines? Note: processed tissues (such as those set in blocks, fixed, onto slides or established tissue culture cell lines) do not require HREC notification. 13. Does this activity involve radiation? If Yes, submit an application for approval to the Animal Ethics Committee animalethics@unisa.edu.au If Yes, submit an application for approval to the Human Research Ethics Committee humanethics@unisa.edu.au If Yes, contact Safety and Wellbeing, HSIM.SafetyWellbeing@unisa.edu.au Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 3 of 18

4 Question Yes No Action Required 14. Does this activity involve highly toxic, hazardous, carcinogenic/teratogenic or cytotoxic chemicals or drugs? If Yes, contact Safety and Wellbeing, Facility Assessment Question Yes No Action Required 15. Does the activity have actual or potential military defence applications? 16. Does the activity have actual or potential commercial applications? 17. Does your activity or project involve the import, export or use of animals (including invertebrates), plants, soils or other materials that require quarantine approval? 18. Has signage been placed outside the laboratory entrances indicating the correct physical containment levels, entry requirements and warning symbols? If Yes, contact Research and Innovation Services If Yes, contact Research and Innovation Services If Yes, ensure all approval conditions are adhered to before commencing the activity or project If No, contact Facility Refer to Appendix 2 for correct containment level. 19. If the project involves Gene Technology, toxins or micro-organisms of Risk Group 2 or greater, has the biohazard symbol been attached to equipment containing biological hazardous material (e.g. fridges, freezers, liquid nitrogen dewars)? 20. Does the laboratory have a copy of the University Biosafety Manual readily accessible to all staff, students or other personnel? 21. If the project involves Gene Technology, toxins or micro-organisms of Risk Group 2 or greater, is access to the laboratory limited to laboratory staff or students and persons specified by laboratory management? If No, contact Facility If No, contact Facility Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 4 of 18

5 Question Yes No Action Required 22. If the project involves Gene Technology, toxins or micro-organisms of Risk Group 2 or greater, are laboratory doors able to be closed when work is in progress? 23. Are spaces under benches, biosafety cabinets and equipment free from clutter and accessible for cleaning? 24. Are aisles and exits free of trip hazards and obstructions to allow unimpeded passage? 25. If the project involves Gene Technology, toxins or micro-organisms of Risk Group 2 or greater, Will laboratory gowns and gloves be worn at all times while work is being conducted in the laboratory? 26. Are eye wash stations or single use packs of sterile eye irrigation fluid provided within the Laboratory? 27. If the project involves Gene Technology, toxins or micro-organisms of Risk Group 2 or greater, are safety glasses and face shields available? 28. If the project involves Gene Technology, toxins or micro-organisms of Risk Group 2 or greater, Will procedures generating aerosols be carried out in a biosafety cabinet? 29. If biosafety cabinets are required for this protocol are they serviced annually? 30. Are work surfaces decontaminated with 70% ethanol or other appropriate disinfectant? 31. Are plunge buckets containing Virkon or other suitable decontaminant available? 32. Are emergency procedures, including spills, evacuation and first aid procedures, displayed in the laboratory? 33. Is a spill kit (containing appropriate disinfectant to decontaminate the biohazard being used, paper towels, gloves, forceps for broken glass, biohazard bags and any other appropriate material) available in case of a spill? If No, contact Facility If No, contact Facility Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 5 of 18

6 Question Yes No Action Required 34. Are all staff members, students or other personnel involved in the activity or project trained in the handling of pathogenic or infectious organisms? 35. Are all staff members, students or other personnel involved in the activity or project trained in the requirements of PC1 OR PC2 facilities? 36. Is all training documented and records kept? 37. If the project involves infectious agents, have all staff members, students or other personnel involved in the activity or project been informed of the potential risks of working with the biohazard whilst pregnant, immunocompromised or immunosuppressed? 38. Have all staff members, students or other personnel involved in the activity or project been informed of the immunisation recommendations 2 for the type of work they will be doing? 39. How will material be disposed at end of project? (e.g. Destruction, transfer, storage). Please note here. Assessment Approval: I am satisfied that the risks are not significant and/or adequately controlled and that resources required will be provided. Investigator Name Signature Date Principal Investigator/Supervisor Name Signature Date Laboratory Coordinator Name Signature Date 2 The Australian Immunisation Handbook, 10th Edition 2013 (Department of Health & Ageing) Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 6 of 18

7 Appendix 1 AS/NZS :2010 Section 3 - Degree of Hazard from Micro-organisms Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 7 of 18

8 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 8 of 18

9 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 9 of 18

10 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 10 of 18

11 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 11 of 18

12 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 12 of 18

13 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 13 of 18

14 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 14 of 18

15 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 15 of 18

16 Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 16 of 18

17 Appendix 2 Appendix 1 - Guide for assigning Containment Level Sample No Human or primate origin? Yes Free from pathogens? No Well-characterised and certified cell line, tissue, fluid or material? Yes Yes Minimal containment level 2 using type II BSC Increased risk resulting from genetic modification No No Increased risk resulting from genetic modification or infection with pathogens? No Increased risk from genetic modification? Yes No Yes Containment level 1 using type II BSC Containment level 1 Level of containment dependant on pathogen and/or genetic modification Yes Appendix 3 CRISPR/Cas, TALEN, ZFN and MNs Clustered regularly interspaced short palindromic repeats/cas (CRISPR/Cas), Transcription activator-like effector nuclease (TALENs), Zinc finger nucleases (ZFN), and meganucleases (MNs) use nucleases to make site-specific double-stranded breaks in the genome. The IBC considers these technologies to fall under the gene technology Act and Regulations in the following ways: 1. Genome editing technology that does not involve introduction of DNA into cells or introduction of technology components into cells that operate through a DNA-intermediate (e.g. reverse transcription systems) or cause changes that are indistinguishable from naturally occurring mutation events do not produce genetically modified organisms. Example: deletion mutations generated by injection of CAS9 mrna and grna into mouse zygotes to create knock-out mice. This does not require a Dealing authorisation from the IBC. Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 17 of 18

18 2. If DNA is introduced into cells (e.g. during genome editing of plants) or homology directed repair is attempted. Example: creating a precisely defined mutation into the mouse genome by injection into mouse zygotes of CAS9 mrna, grna and an oligonucleotide bearing the mutation sequence. This requires approval from the IBC under Exempt or NLRD classification, as defined by the Office of the Gene Technology Regulator (OGTR,) prior to commencing the work. Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 Page 18 of 18

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