Biosafety at Swinburne Sheila Hamilton-Brown Executive Officer, SBC

Overview Definition of Biohazard and Biosafety The Swinburne Biosafety Committee (SBC) Your role Frequently Asked Questions (FAQs)

Biohazards (biological hazards) Infectious agents or other hazardous biological materials that present a risk or potential risk to the health of humans, animals, or the environment. e.g. some recombinant DNA infectious viruses bacteria, fungi and prions toxins, allergens, and venoms Biohazards (biological hazards) are infectious agents or other hazardous biologic materials that present a risk or potential risk to the health of humans, animals, or the environment. The risk can be direct through infection or indirect through damage to the environment. Examples are certain types of recombinant DNA; organisms and viruses infectious to humans, animals, or plants (e.g., parasites, viruses, bacteria, fungi, prions, and rickettsia); biologically active agents (e.g., toxins, allergens, and venoms) that can cause disease in other living organisms or cause significant impact to the environment or community. 3

Biosafety Biosafety defines the containment conditions under which infectious agents can be safely used. The objective of containment is to confine biohazards, and to reduce the exposure to human health and the environment to infectious agents. Biosafety correlates to the obligation to ensure that the necessary safety precautions are taken, when conducting activities not prohibited under Federal/State regulations to protect the community and the environment. 4

Swinburne Biosafety Committee (SBC) Members have expertise in Biosafety Committee Molecular plant biotechnology Biochemistry Molecular biology Genetics Ethics Bioengineering Laboratory technology Physical chemistry Bioelectromagnetic safety Laboratory and biosafety The Swinburne Biosafety Committee (SBC) was formed to: To assess, approve, inspect or monitor activities including the safe production, handling, storage and containment of biohazardous material; particularly Genetically Modified Organisms (GMOs), as well as potentially infectious microorganisms as described in the Australian Standard AS/NZ 2243.3 (Risk Group 2 or higher), Security Sensitive Biological Agents (SSBAs), and materials regulated by quarantine and biosecurity legislation. To assess, approve, inspect or monitor facilities relating to or involving biohazardous material, including advising on or determining whether proposed facility complies with regulated (OGTR-certified, Quarantine Approved Premises) and certain physical containment facilities (e.g. Australian Standard AS/NZ 2243.1) requirements. To advise on, develop, revise or approve policies, guidelines and procedures for the safe handling or storage of biohazardous material, including with respect to training and qualifications of personnel involved. 5

Swinburne Biosafety Committee The SBC is responsible for: monitoring inspecting approving assessing The Swinburne Biosafety Committee (SBC) was formed to: To assess, approve, inspect or monitor activities including the safe production, handling, storage and containment of biohazardous material; particularly Genetically Modified Organisms (GMOs), as well as potentially infectious microorganisms as described in the Australian Standard AS/NZ 2243.3 (Risk Group 2 or higher), Security Sensitive Biological Agents (SSBAs), and materials regulated by quarantine and biosecurity legislation. To assess, approve, inspect or monitor facilities relating to or involving biohazardous material, including advising on or determining whether proposed facility complies with regulated (OGTR-certified, Quarantine Approved Premises) and certain physical containment facilities (e.g. Australian Standard AS/NZ 2243.1) requirements. To advise on, develop, revise or approve policies, guidelines and procedures for the safe handling or storage of biohazardous material, including with respect to training and qualifications of personnel involved. Swinburne activity (research or teaching) and facilities involving the use of…. 6

Genetically Modified Organisms (GMOs) Security Sensitive Biological Agents (SSBAs) Infectious microorganisms AS/NZS 2243.3 Quarantine and Biosecurity materials Especially as regards the following regulated biohazards. Genetically Modified Organisms (GMOs) which are regulated by the Office of the Gene Technology Regulator (OGTR) Infectious microorganisms which whilst not strictly regulated as such, are classified as in the AS/NZS 2243.3 and these not only spell out the risks to the people and the environment, but also the way labs and other facilities needs to be structured. Security Sensitive Biological Agents (SSBAs) and Quarantine and Biosecurity materials are microorganisms that may be used in bioterrorism or biocrime and consequently are highly regulated. We don’t have any of these at Swinburne as we currently don’t have the facilities for them. But if you need to use them, please let us know and we can help you identify the proper facilities in Melbourne. …is safely contained, never exposed to the environment and never affects human health 7

Your role 1. Identify your biohazard Research Supervisor Lab Manager 2. Seek SBC approval Complete application form + Standard Operating Procedures (SOPs) + Risk Assessments 3. Complete lab inductions & training Use of PC2 labs Relevant equipment What do you need to do? You need to prove to the SBC that you know what you are working with, and show how you are going to safely work with the biohazard and contain to protect the community and the environment: 1. Identify the biohazard: Do your homework to find what you are using and the biohazard is Speak to your supervisor Lab manager 2. Seek approval from the SBC for biosafety approval Filling out the appropriate forms (i.e. application, standard operating procedures and risk assessments) Submit to the SBC on the due date as indicated in the Research Bulletin (Special Announcements – Ethics) Do not start work until you have hear further from the SBC. 3. Inductions and training Lab inductions specifically the PC2 training How to use the relevant equipment esp. Biosafety cabinet (did you know you shouldn’t use a bunsen burner in a BSC?) 8

Infectious microorganisms FAQs What is the difference between PC2 labs certified for GMOs (OGTR) and infectious microorganisms? OGTR NLRD and Exempt GMO dealings can only be used in these labs Formal certification process similar classification system, but some important differences e.g. inward air-flow Infectious microorganisms Risk Group 2 organisms can only be used in these labs No formal certification process but facilities should conform to AS 2232.3 Aerosol-producing work must be confined to Biosafety cabinets (BSC) Now I am going to talk to you about Frequently asked questions. I am regularly told that someone needs to use the OGTR PC2 lab to do work on a Risk group 2 organisms, not necessary. If a lab has OGTR certification, then it should have this orange sticker – this means that it has been formally certified by the Office of the Gene technology Regulator – the SBC actually do this. 9

FAQs I have an NLRD (Notifiable low risk dealing). When can I start working in the laboratory? 1. Go through the SBC approval process 2. Complete a Record of Assessment 3. Complete your lab induction and OGTR biosafety training FAQs 10

2. Complete your lab induction and biosafety training FAQs I want to use a Risk Group 2 organism for my research. The organism has been sourced from my Swinburne supervisor’s stock. What do I need to do to start working in the laboratory? 1. Read and sign the SBC-approved generic Risk Group 2 bacteria or cell lines documents 2. Complete your lab induction and biosafety training 11

FAQs I want to use some Risk Group 2 bacteria sourced from another institution. What do I need to do to start working in the laboratory? 1. Complete a notification of Risk Group 2 agent form 2. Read and sign the SBC-approved generic Risk Group 2 bacteria or cell lines documents 3. Complete your lab induction and biosafety training 12

FAQs What about human cell lines obtained from commercial vendors or sources with documented testing to be free of human bloodborne pathogens? We treat such cell lines as we do for Risk Group 2 microorganisms 1. Read and sign the SBC-approved generic Risk Group 2 cell lines document 2. Complete your lab induction and biosafety training FAQs 13

What Next? Contact: Executive Officer shamiltonbrown@swin.edu.au 03 9214 5935 14