IBC-1.3 BIOHAZARD RISK ASSESSMENTw3.unisa.edu.au/res/ethics/docs/Biohazard Risk Assessment...

IBC-1.3

Biohazard Risk Assessment Form IBC-1.2 Institutional Biosafety Committee December 2016 of 18 Disclaimer: Hardcopies of this document are considered uncontrolled. Please refer to the RIS Ethics & Integrity website for the latest version.

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?

If “Yes” no biological hazard or gene technology application required. See “Other Approvals”

3. Does the protocol involve the use of genetically naïve micro-organisms?

If “Yes”, Refer to Appendix 1 – AS/NZS 2243.3:20101” Section 3 - Degree of Hazard from Micro-organisms to determine risk level.

1 The Standard AS/NZS 2243.3:2010 Part 3: Microbiological safety and containment” may be accessed through the SAI Global public database, Standards Online, via the University library.

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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? Note: It has been reported that about 30% of laboratory mice are infected with norovirus. Lab.Ani. 2009 43:165-173

If “Yes”, Refer to Appendix 1 – AS/NZS 2243.3:2010 Section 3 - Degree of Hazard from Micro-organisms to determine risk level

5. 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?

If “Yes”, Refer to Appendix 1 – AS/NZS 2243.3:2010 Section 3 - Degree of Hazard from Micro- organisms, to determine risk level of the infectious agent.

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?

If “Yes”, Refer to Appendix 1 – AS/NZS 2243.3:2010 Section 3 - Degree of Hazard from Micro- organisms to determine risk level of the infectious agent.

7. Are there any unmodified biologicals involved in this project which are not listed in Appendix 1 - AS/NZS 2243.3:2010 Section 3 - Degree of Hazard from Micro-organisms

If “Yes”, determine the risk level in your professional judgment in reference to AS/NZS 2243.3:2010. You are welcome to consult with the Chair of the IBC.

8. Does the protocol involve the use of unmodified biologicals which are Risk Group 2 or greater?

If “Yes”, submit a copy of this risk assessment and a Biological Hazard Application to [email protected] Work must not commence before approval from the Institutional Biosafety Committee is granted.

http://search.library.unisa.edu.au/record/UNISA_ALMA6184616600001831

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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?

If “Yes”, submit a copy of this risk assessment and a Biological Hazard Application to [email protected] Work must not commence before approval from the Institutional Biosafety Committee is granted.

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 an application for Exempt and Notifiable Low Risk Dealings to [email protected] 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.

If “Yes”, submit an application for approval to the Animal Ethics Committee [email protected]

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.

If “Yes”, submit an application for approval to the Human Research Ethics Committee [email protected]

13. Does this activity involve radiation? If “Yes”, contact Safety and Wellbeing, [email protected]

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14. Does this activity involve highly toxic, hazardous, carcinogenic/teratogenic or cytotoxic chemicals or drugs?

If “Yes”, contact Safety and Wellbeing, [email protected]

Facility Assessment


15. Does the activity have actual or potential military defence applications?

If “Yes”, contact Research and Innovation Services [email protected]

16. Does the activity have actual or potential commercial applications?

If “Yes”, contact Research and Innovation Services [email protected]

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?

If “Yes”, ensure all approval conditions are adhered to before commencing the activity or project

18. Has signage been placed outside the laboratory entrances indicating the correct physical containment levels, entry requirements and warning symbols? Refer to Appendix 2 for correct containment level.

If “No”, contact Facility Manager.

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?

If “No”, contact Laboratory Manager.

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?


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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? If “No”, contact Laboratory

Manager.

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? If “No”, contact Facility Manager.

30. Are work surfaces decontaminated with 70% ethanol or other appropriate disinfectant? If “No”, contact Laboratory

Manager.

31. Are plunge buckets containing Virkon or other suitable decontaminant available? If “No”, contact Laboratory

Manager.

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?


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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? If “No”, contact Laboratory Manager.

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 recommendations2 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)

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Appendix 1 AS/NZS 2243.3:2010 Section 3 - Degree of Hazard from Micro-organisms

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Appendix 2

Sample

Human or primate origin?

Free from pathogens?

Increased risk from genetic modification?

No

Yes

No

Containment level 1

Well-characterised and certified cell

line, tissue, fluid or material?

Yes

Minimal containment level 2 using type II BSC

Level of containment dependant on pathogen and/or genetic

modification

No

Increased risk resulting from

genetic modification

Yes

Yes

Increased risk resulting from genetic modification or

infection with pathogens?

Yes

Containment level 1 using type II BSC

No

Yes

No

Appendix 1 - Guide for assigning Containment Level

No

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.

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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.

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