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SCIENCE | TECHNOLOGY | INNOVATION

Swinburne Biosafety Committee. Presentation title. Biosafety Training Module. SCIENCE | TECHNOLOGY | INNOVATION. Swinburne Biosafety Committee . Presentation title.

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SCIENCE | TECHNOLOGY | INNOVATION

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  1. Swinburne Biosafety Committee • Presentation title Biosafety Training Module SCIENCE | TECHNOLOGY | INNOVATION

  2. Swinburne Biosafety Committee • Presentation title The Swinburne Biosafety Committee (SBC) is responsible for reviewing and approving Swinburne activity (research and teaching) or facilities involving genetically modified organisms (GMO) and biohazardousmaterials. SCIENCE | TECHNOLOGY | INNOVATION

  3. Swinburne Biosafety Committee • You will need SBC approval/notification for matters involving • GMOs & certification of physical containment facilities in which GMO dealings will be conducted • Security Sensitive Biological Agents (SSBAs) • Organisms in Risk Group 2, 3 or 4 in the AS/NZS 2243.3:2010 or procedures that may result in the isolation or enrichment of such organisms • All human tissue or blood products • Cultured primary mammalian cells or mammalian cell lines likely to contain infectious agents • Material of biological origin that may be or may contain a hazard to humans e.g. toxins, allergens, prions • Quarantine materials in any of the above categories SCIENCE | TECHNOLOGY | INNOVATION

  4. Topics to be covered • Presentation title • Genetically Modified Organisms (GMO) • Quarantine • Microorganisms SCIENCE | TECHNOLOGY | INNOVATION

  5. What is a GMO? • an organism that has been modified by Gene Technology (GT*); or • an organism that has inherited traits from an organism that occurred in the initial organism because of GT *GT = any technique for the modification of genes or other genetic material, but does not include: • sexual reproduction • homologous recombination • any other technique specified in the regulations. SCIENCE | TECHNOLOGY | INNOVATION

  6. What is not a GMO? • Naturally occurring mutations • Fusion of animal cells (unless the product can form an animal) • Plants formed by protoplast fusion, embryo rescue or in vitro fertilisation or zygote implantation • Organisms formed by natural DNA transfer (modified with permission from Curtin University Health and Safety) SCIENCE | TECHNOLOGY | INNOVATION

  7. GMO Regulation • Gene Technology (GT) Act 2000 • Gene Technology Regulations 2001 • Federal Administration via the Office of the Gene Technology Regulator (OGTR) • States have mirror regulations • Regulations reviewed and updated regularly SCIENCE | TECHNOLOGY | INNOVATION

  8. Object of the GT Act (2000) • to protect the health and safety of people, and the environment: • by identifying risks posed by or as a result of gene technology, and • by managing those risks through regulating certain dealings with genetically modified organisms (GMOs). SCIENCE | TECHNOLOGY | INNOVATION

  9. Office of the Gene Technology Regulator (OGTR) • Accreditation of organisations • Ensures that sufficient oversight is in place • IBC = Institutional Biosafety Committee • Certification of facilities • Ensures conditions necessary to minimise risk are maintained (e.g. PC2 laboratories and glasshouses) • Certification of dealings • Ensures that dealings are undertaken safely, in appropriate facilities, considers ethics and ensures there is a record. • Ensures researchers are appropriately trained/responsible SCIENCE | TECHNOLOGY | INNOVATION

  10. What is a GMO ‘dealing’? • Defined in the regulations • conduct experiments with the GMO; • make, develop, produce or manufacture the GMO; • breed the GMO; • propagate the GMO; • use the GMO in the course of manufacture of a thing that is not a GMO; • grow, raise or culture the GMO; • import the GMO; • transport the GMO; • dispose of the GMO; • includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned above . SCIENCE | TECHNOLOGY | INNOVATION

  11. Types of ‘Dealings’ • Exempt dealings - Low risk, negligible consequences from release • Notifiable low risk dealings (NLRDs) - Low risk as long as certain conditions are adhered to. • Dealings not involving release (DNIRs) - Medium risk, mostly due to potential for harm (to people or environment) from unintentional release – allows the OGTR to impose conditions to manage risk • Dealings involving release (DIRs) - High risk • Emergency Dealing Determination (EDD) SCIENCE | TECHNOLOGY | INNOVATION

  12. Regulating GMO dealings • www.ogtr.gov.au • Regulations • www.comlaw.gov.au/Details/F2011C00732/Download • Regulations contain detailed Schedules • Schedules define the category to which a dealing belongs SCIENCE | TECHNOLOGY | INNOVATION

  13. Schedules • Schedule 1A: Techniques that are not GT • Schedule 1: Organisms that are not GM • Schedule 2: Dealings exempt from licensing • Part 1 Exempt dealings • Part 2 Host/vector systems for exempt dealings • Part 3 Definitions • Schedule 3: NLRDs in relation to a GMO • Part 1 NLRDs suitable for at least PC1 containment • Part 2 NLRDs suitable for at least PC2 or PC3 containment • Part 3 Dealings that are not NLRDs SCIENCE | TECHNOLOGY | INNOVATION

  14. Physical Containment (PC) facilities The OGTR has adopted the four-tier classification system based on AS/NZS 2243.3 for certifying facilities suitable for GMO dealings • PC1 • PC2 • PC3 • PC4

  15. Physical Containment (PC) facilities Dealings must be conducted in a facility certified by the OGTR at a level appropriate to the potential risk posed by the dealing. • Exempt - Not necessary, but recommend PC1 →PC2 • NLRD - PC1→PC3 • DNIR - PC2 → PC4 • DIR → outside containment facilities NB: PC4 is not applicable in the Swinburne context.

  16. Dealings at Swinburne • Exempt • NLRD • DNIR • DIR NB: DNIR & DIRnot applicable in the Swinburne context. SCIENCE | TECHNOLOGY | INNOVATION

  17. Exempt dealings • Examples • GM C. elegans • GM of the somatic cells of an animal • Dealings using host/vectors from schedule 2 • For example; • E. coli/non-conjugative plasmids • animal cell culture/baculovirus vectors • But; • Donor gene must be characterised, not a toxin, no history of causing disease, not able to restore replication competence of the vector... Etc., etc., etc. Note: devil’s in the detail – read the fine print! SCIENCE | TECHNOLOGY | INNOVATION

  18. Exempt dealings • Must be assessed by Swinburne Biosafety Committee • May be undertaken in a non-OGTR certified facility but recommend PC2 • Best practice • Maintain good laboratory practice • GMOs should not be released into the environment SCIENCE | TECHNOLOGY | INNOVATION

  19. NLRD • Notifiable Low Risk Dealing • Must have SBC approval BEFORE the dealing starts • Must be undertaken in PC2 & PC 3 labs • Specific guidelines for behaviours within certified labs (see later) • PC1, PC2 and PC3 type dealings SCIENCE | TECHNOLOGY | INNOVATION

  20. NLRD-PC1 dealings • GM mouse, rat, guinea pig, rabbit • Replication defective adenoviral vectors • Must not restore competence of the vector • No genes that confer oncogenic modifications in humans • No genes that encode proteins with immunomodulatory activity in humans SCIENCE | TECHNOLOGY | INNOVATION

  21. NLRD – PC2 dealings • GM of whole animals (except mouse etc) • GM of plants • exempt host/vectors where the conditions for exempt status are not met • Non-exempt host/vectors • Volumes >25L • Viral vectors (assorted subcategories) Note: devil’s in the detail – read the fine print! SCIENCE | TECHNOLOGY | INNOVATION

  22. NLRD – PC3 dealings • Any NLRD type dealing involving a risk group 3 micro-organism SCIENCE | TECHNOLOGY | INNOVATION

  23. Working with NLRDs? • Undertake OGTR PC2 training • Observe behavioural requirements SCIENCE | TECHNOLOGY | INNOVATION

  24. OGTR-Certified PC2 behavioural guidelines Access and Egress • Restricted to authorised personnel • All doors and windows must be closed Non GMO • Procedures must be in place to prevent cross contamination Aerosols • Work that produces an aerosol must be performed in a Biological Safety Cabinet SCIENCE | TECHNOLOGY | INNOVATION

  25. PC2 behavioural guidelines Decontamination • All decontamination procedures must be carried out by trained personnel. •   GMOs must be rendered non-viable prior to disposal. •   Wastes containing GMOs must be decontaminated prior to disposal. •   Work benches, surfaces and equipment must be decontaminated when the dealings are completed. •   Equipment must be decontaminated before being removed from the facility. SCIENCE | TECHNOLOGY | INNOVATION

  26. PC2 behavioural guidelines Decontamination can be effected by • Autoclave • Chemical • Bleach (5000ppm sodium hypochlorite = 0.5%) • Household bleach = 4% sodium hypochlorite • 1/8 dilution = final concentration of 0.5% hypochlorite • Freshly prepared (same day) • Do not autoclave bleach SCIENCE | TECHNOLOGY | INNOVATION

  27. Transport • Between laboratories, buildings, campuses • Double contained • Sealed unbreakable containers • Labelled • Decontaminate (e.g. 80% ethanol spray) • Primary container prior to packing • Secondary (outside) container prior to leaving the lab SCIENCE | TECHNOLOGY | INNOVATION

  28. Spills If a spill occurs outside the facility: • All spilt material must be recovered and contaminated surfaces decontaminated. • Any real or suspected unintentional release must be reported to the SBC and OGTR as soon as reasonably possible. SCIENCE | TECHNOLOGY | INNOVATION

  29. Your responsibilities • Everyone • Work safely • Look after yourself and those around you • Wear/use appropriate PPE • Attend training sessions • Keep accurate records of your GM work • Know which regulations affect your work (and comply with them) • Chief Investigators/Project leaders • Get approval for GM work from the Swinburne Biosafety Committee • Ensure work is undertaken in an appropriately certified facility • Ensure GM records are kept • Ensure all people working with GMOs have appropriate training • Ensure appropriate supervision is maintained • Are responsible for staff and students working on project • Provide annual reports • Duty of care to those you supervise SCIENCE | TECHNOLOGY | INNOVATION

  30. Penalties – defined in GT Act • Breach of GMO licence (eg DNIR/DIR) • Each day the breach occurs is considered a separate offence! • Aggravated offence = significant damage to health and safety of people or the environment • 5 years imprisonment or 2000 penalty units ($1.1 million) • Other cases • 2 years imprisonment or 500 penalty units ($55,000) • Breach of NLRDs • 50 penalty units ($5,500) SCIENCE | TECHNOLOGY | INNOVATION

  31. Quarantine • The Department of Agriculture, Fisheries and Forestry (DAFF, formally AQIS) control Australia's borders to minimise the risk of exotic pests and diseases and agriculture industries and the environment. • DAFF determine the conditions for import, export and containment of quarantine goods. SCIENCE | TECHNOLOGY | INNOVATION

  32. Quarantine • Any work with quarantine items may need • an Import Permit (Biological Materials, Plant Materials, Live Animals) • storage in Quarantine Approved Premises (QAP) • training as a QAP Accredited Person • The Biosecurity Bill 2012 replaces the Quarantine Act 1908 and has significant changes to offences, penalties and enforcement provisions. NB: Swinburne currently does not have a QAP or a QAP Accredited Person SCIENCE | TECHNOLOGY | INNOVATION

  33. Microorganisms • The basic approach to working with microorganisms is to regard them as potential pathogens and to handle them with standard microbiological techniques. • AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment classifies microorganisms into four risk groups and specifies work requirements for the corresponding four physical containment levels. SCIENCE | TECHNOLOGY | INNOVATION

  34. Microorganisms Some important points: • Persons who are immuno-suppressed, immuno-compromised, or otherwise unduly vulnerable to infection, such as persons who are diabetic, should inform their supervisor or person responsible for microbiological safety of their condition so that appropriate action may be taken. • Laboratory management shall inform all female employees of the risk to the unborn child or the pregnant woman of occupational exposure to certain microorganisms (e.g. Toxoplasma gondii, Listeria monocytogenes, cytomegalovirus, parvovirus B19, rubella virus, human immunodeficiency virus (HIV), Coxiellaburnetiiand hepatitis B, C and E viruses) and some fungi. SCIENCE | TECHNOLOGY | INNOVATION

  35. Microorganisms Risk group categories: (a) Risk Group 1 (low individual and community risk)—a microorganism that is unlikely to cause human or animal disease. (b) Risk Group 2 (moderate individual risk, limited community risk)—a microorganism that is unlikely to be a significant risk to laboratory workers, the community, livestock, or the environment; laboratory exposures may cause infection, but effective treatment and preventive measures are available, and the risk of spread is limited. (c) Risk Group 3 (high individual risk, limited to moderate community risk)—a microorganism that usually causes serious human or animal disease and may present a significant risk to laboratory workers. It could present a limited to moderate risk if spread in the community or the environment, but there are usually effective preventive measures or treatment available. (d) Risk Group 4 (high individual and community risk)—a microorganism that usually produces life-threatening human or animal disease, represents a significant risk to laboratory workers and may be readily transmissible from one individual to another. Effective treatment and preventive measures are not usually available. SCIENCE | TECHNOLOGY | INNOVATION

  36. Microorganisms Risk group and physical containment (PC) facilities • Risk Group 1 = PC1 • Risk Group 2 = PC2 • Risk Group 3 = PC3 • Risk Group 4 = PC4 Human and animal clinical and diagnostic specimens would normally be regarded as Risk Group 2 and shall be handled in PC2 facilities unless a higher risk group is indicated by the clinical notes. SCIENCE | TECHNOLOGY | INNOVATION

  37. Microorganisms Examples of Risk Group 2 parasites Examples of Risk Group 2 bacteria SCIENCE | TECHNOLOGY | INNOVATION (reproduced from AS/NZS2243.3:2010)

  38. Safety with microorganisms Examples of Risk Group 4 viruses Examples of Risk Group 3 viruses SCIENCE | TECHNOLOGY | INNOVATION

  39. SBC approval/notification • All work involving: • GMOs & certification of physical containment facilities in which GMO dealings will be conducted • Security Sensitive Biological Agents (SSBAs) • Organisms in Risk Group 2, 3 or 4 in the AS/NZS 2243.3:2010 or procedures that may result in the isolation or enrichment of such organisms • All human tissue or blood products • Cultured primary mammalian cells or mammalian cell lines likely to contain infectious agents • Material of biological origin that may be or may contain a hazard to humans e.g. toxins, allergens, prions • Quarantine materials in any of the above categories • must be approved by the Swinburne Biosafety Committee, through the Research Ethics Office, prior to commencing. SCIENCE | TECHNOLOGY | INNOVATION

  40. Research Ethics Office • Advice on regulatory and institutional requirements for the use of genetically modified organisms and biologically hazardous materials. • Secretariat support to the Swinburne Biosafety Committee (SBC) Further contact details: Secretary, SBC / Biosafety Officer Research Ethics Office Swinburne Research (H68) Swinburne University of Technology PO Box 218 HAWTHORN VIC 3122 Tel: 9214 5935 E-mail: resethics@swin.edu.au www.research.swinburne.edu.au/ethics/biosafety/ SCIENCE | TECHNOLOGY | INNOVATION

  41. Code breaker! • AQIS = Australian Quarantine and Inspection Service • DAFF - Department of Agriculture, Fisheries and Forestry • DIR = dealing involving (intentional) release • DNIR = dealing not involving release • EDD = emergency dealing determination • GMO = genetically modified organism • GT = gene technology • IBC = Institutional Biosafety Committee • NLRD = notifiable low risk dealing • OGTR = Office of the Gene Technology Regulator • PC = physical containment, e.g. PC2 laboratory • QAP - Quarantine Approved Premises SCIENCE | TECHNOLOGY | INNOVATION

  42. Regulating GMO dealings – extra info • Exempt Dealings - certain types of dealings with GMOs which involve a very low risk (i.e. contained research involving very well understood organisms and processes for creating and studying GMOs). Other then listing in the Regulations, the only legislative requirement for exempt dealings is that they must not involve an intentional release of a GMO into the environment. • Notifiable Low Risk Dealings - the regulations also set out categories of dealings with GMOs which are low risk and which may proceed provided that certain conditions spelt out in the regulations are observed. This includes requirements that the specified dealings be undertaken only in certified contained facilities, overseen by Institutional Biosafety Committees (IBCs) and notified annually to the Regulator. The conditions under which such dealings must be conducted are clearly set out in the regulations. An NLRD must not involve the intentional release of a GMO into the environment. • Licences - all dealings with GMOs (that are not exempt or NLRDs or on the GMO Register) need to be licensed by the Regulator. The licensing system is based on rigorous scientific risk assessment and extensive consultation with expert advisory committees, Government agencies and, for intentional releases of GMOs into the environment, the public. • GMO Register - dealings with GMOs may be entered on the GMO Register once they have been licensed for a certain period of time. Dealings will not be entered onto the Register until the Regulator is satisfied that the dealings are sufficiently safe that they can be undertaken by anyone, and that safety does not depend on oversight by a licence holder. • Emergency Dealing Determination (EDD) - the Minister may make an EDD authorising dealings with GMOs for a limited period in an emergency. The Minister must be satisfied that there is an actual or imminent threat to people or the environment, that the EDD would adequately address the threat and that risks posed are able to be managed so as to protect people and the environment. The Minister must receive advice from the Regulator to management of risks. SCIENCE | TECHNOLOGY | INNOVATION

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