Procedures

Biosafety Requirements - Procedures

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1. Purpose and Objectives

This procedure outlines the requirements for work involving biological material or for working in areas where biological material is used at the University of Queensland in accordance with the relevant legislative requirements. This encompasses work with, but not exclusively with, high risk biological material (Risk Groups 2 and 3), dealings involving Genetically Modified Organisms (Exempt, NLRD, DNIR and DIR), quarantine material, toxic or venomous animals and volumes of Risk Group 2 material greater than 10L.

2. Definitions, Terms, Acronyms

Accredited Organisation - An organisation or entity that has been accredited for GM research/dealings by the OGTR

AS/NZS 2243.3: 2010 - Australian/New Zealand Standard 2243.3:2010 Safety in laboratories: Microbiological safety and containment

Biological Material - includes, but is not limited to blood, blood products, tissues, body fluids and any derivatives produced by chemical or physical means; micro-organisms – wild type or mutant; plants and plant material

Biosafety - measures relating to the protection of an environment or population etc. from contamination with or infection by a biological agent

DAgWRB - Commonwealth Department of Agriculture and Water Resources Biosecurity section responsible for quarantine (formerly DAFF – Biosecurity, formerly AQIS)

Dealing - as defined by the OGTR – conduct experiments with GMOs; make, develop, produce, manufacture GMOs; breed; propagate; use GMOs in the manufacturing of non GM products; grow, raise, culture GMOs; import GMOs; transport or store GMOs

DIR - Dealings involving Intentional Release. This is a licence issued to an Accredited Organisation to undertake high risk dealings outside the containment facilities such as laboratory or glasshouse.

DNIR - Dealings Not Involving Intentional Release. This is a licence issued to an Accredited Organisation to undertake high risk dealings within a certified facility such as laboratory or Glass house.

DSGL - Defence Strategic Goods List, identified in Regulation 13E of the Customs (Prohibited Exports) Regulations 1958 (C’th)

Exempt Dealing - a type of GM dealing, one that poses a very low risk

GM/GMO/GMMO - Genetic Modification/Genetically Modified Organism/Genetically Modified Microorganism

Grey Folder - a system used by UQ Biosafety whereby a collection of compliance documents is held at the local PC1 or PC2 laboratory

High Risk Biological Material - specified by the UQ IBC and described in PPL 2.40.15 Working with Potentially Hazardous Biologicals

IBC - Institutional Biosafety Committee, a Committee that is established by an Accredited Organisation, as required by the OGTR

IBSC - Institutional Biosafety Sub-Committee

OGTR - Office of the Gene Technology Regulator

PC1, PC2, PC3 Certified facilities/Certified facilities - Physical Containment facilities certified by the OGTR

PC1, PC2, PC3 Biological Hazard facilities - Physical Containment facilities for infectious microorganisms as described in AS/NZS 2243.3 2010

PPE - Personal Protective Equipment

QAP - Quarantine Approved Premises

Regulations - Refers to the Gene Technology Regulations 2001 (C'th)

Risk Group 1-4/RG1-4 - Infectious micro-organisms as defined in AS2243.3 2010, Risk Group 1 being the lowest risk and Risk Group 4 being the highest risk

SOP - Safe Operating Procedure

SSBA - Security Sensitive Biological Agents- biological agents as regulated by the National Health Security Act 2007 (C’th)

3. Procedures Scope/Coverage

These procedures apply to all staff, students, visitors, volunteers and contractors who are working with biological material or working in areas where biological material is used.

4. Procedures Statement

These procedures assist personnel working with biological material in ensuring that they are compliant with the requirements of relevant legislation, regulations and guidelines that apply to them and the work that they are performing when working with biological material. Following the correct procedures ensures that the facilities being used for the work are suitable for containing the specified biological material, that they have permission from the Institutional Biosafety Committee or its Sub-Committee and the facility owner/manager to undertake the work and they have had correct and appropriate training before undertaking the work.

5. Principles of Biosafety

The principles of biosafety at The University of Queensland are summarised below:

  • Ensure the protection of the health and safety of personnel and the work environment involving the use of biological material at UQ premises or by UQ staff, students, visitors, volunteers or contractors
  • Ensure appropriate containment of biological material, including but not limited to genetically modified organisms (GMOs), quarantine and infectious material and biological toxins/animal/plants in accordance with the requirements of the Office of the Gene Technology Regulator (OGTR), Department of Agriculture and Water Resources - Biosecurity and AS/NZS 2243.3:2010
  • Ensure safe and correct laboratory practices are undertaken by staff, students and visitors whilst in UQ facilities or by staff and students working on behalf of the University (includes risk assessments and SOPs)
  • Ensure the correct selection and use of PPE
  • Ensure the correct and relevant training has been completed prior to commencing work.

6. Key Areas of Biosafety

6.1 Dealings involving genetic manipulations

Dealings involving genetic manipulation are governed by the Gene Technology Act 2001 (C'th) and Regulations 2001 (C'th). The University of Queensland is a registered Accredited Organisation with the OGTR and has an established Institutional Biosafety Committee (IBC). Dealings involving Genetically Modified Material must be submitted to the IBC Sub-Committee for consideration and subsequent approval.

Dealings include the possession, use, transport, storage or disposal of the GMO for purposes of, or in the course of a dealing mentioned in points 1 to 7 below.

  1. Conduct experiments with GMOs
  2. Make, develop, produce, manufacture GMOs
  3. Breed GMOs
  4. Propagate GMOs
  5. Use GMOs in manufacturing of non GM products
  6. Grow, raise, culture GMOs
  7. Import GMOs

GM dealings fall into four main categories. Researchers should consult the Gene Technology Regulations 2001 (C'th) to determine which category their research falls into:

  • Exempt (a proposal must still be submitted to the IBSC)
  • Notifiable Low Risk Dealing (NLRD)
  • Licenced dealings NOT for Intentional Release (DNIR)
  • Licenced dealings for Intentional Release (DIR)

Exempt and NLRD forms are available from the relevant entry under PPL 2.40 Biosafety. Please consult PPL 2.40.04 Notifiable Low Risk Dealings and PPL 2.40.03 Containment of Exempt Dealings for further information and help in completing the correct form. All other forms can be obtained directly from the OGTR website.

6.1.1 Storage and labelling of GM material

The OGTR requirements for storage and labelling of GMOs are outlined in the OGTR Guidelines for Transport, Storage and Disposal of GMOs (2011). It is a requirement by the OGTR that adequate storage records and labelling procedures are in place in order to easily identify biological samples stored both inside and outside certified facilities. This enables both the separation and identification of different types of biological material stored and the easy identification of stored GMO/GMMO samples during audits by the OGTR.  In shared spaces and group storage areas, accurate labelling and record keeping is also important.

Please consult PPL 2.40.07 Storage and Labelling Requirements for Genetically Modified Organisms for detailed instructions and examples for storage and labelling of samples in fridges, freezers, cold rooms, liquid nitrogen dewars etc. to meet these requirements.

6.1.2 Working with retroviral vectors

Retroviral vectors, including lentiviral vectors, are a common tool used by researchers to introduce a gene into the genome of a target cell or organism due to their ability to transduce a wide range of cell types and the ability of some lentiviral vectors in particular to infect both dividing and non-dividing cells.

The efficiency of vectors that are able to transduce human cells comes with some inherent risk, namely the possibility for the generation of replication competent retroviral particles, and also the accidental delivery of genes that may confer an oncogenic modification. Progressive generations of vector systems have become available that minimize these possibilities by splitting the components of the packaged retro/lentivirus into multiple plasmids.  The new systems are less efficient but also provide a considerably reduced risk of the generation of a replication competent retrovirus.

Please consult PPL 2.40.05 Working with Retroviral Vectors for further information and considerations on how to minimise risks involved in this work.

6.2 Working with potentially hazardous biological material

Any work involving potentially hazardous biological material requires approval from the UQ IBSC.

The following classes and types of organisms may be considered as hazardous:

  • Risk Group 2 microorganisms cultured in large volumes (greater than 10 litres) or those that require special precautions such as requiring vaccination, or are dangerous to pregnant women
  • Risk Group 3 or 4 microorganisms (Please Note: The University has no facilities capable of containing Risk Group 4 organisms)
  • Infectious/potentially infectious animals, tissues or fluids involving microorganisms of the categories mentioned above
  • Unscreened specimens (i.e. human tissue or body fluids that are known to contain microorganisms listed above, or that have not been screened for infectious disease; animal tissue or body fluids that could contain zoonoses or that have not been screened for such)
  • Poisonous or venomous animals (e.g. snakes, spiders, cone-shells)
  • Biological toxins (excluding toxoids)
  • Biological toxins on the Defence Strategic Goods List (DSGL)
  • Security sensitive biological material (SSBA)

Biological toxins listed in the Defence Strategic Goods List and Security Sensitive Biological Material schedule require extra requirements such as upgraded security and police background checks. The process of obtaining permission to work with such material may take a considerable time to process. Please bear this in mind. Please consult UQ Biosafety and advise if you intend to work with such material. Please consult PPL 2.40.15 Working with Potentially Hazardous Biologicals for further information and application forms.

6.2.1 Precautions

Universal precautions when working with clinical and diagnostic specimens, blood and tissue samples (screened and unscreened) include:

  • Washing hands,
  • Care of intact skin,
  • Protection of damaged skin, and
  • Proper handling and disposal of sharp objects.

Personal protection must be worn and be available i.e. gloves, lab gowns, waterproof aprons, P2 masks and protective eye wear must be worn where appropriate. Persons with cuts or abrasions on exposed body parts must cover these with waterproof dressings. Education and training in preventative measures should be carried out and safe work procedures developed for all activities with the potential for hazard exposure. Further information on working with unscreened specimens can be found in PPL 2.60.10 Working Safely with Blood and Body Fluids.

Work with risk group 2, 3 or 4 material must be conducted in facilities suitable for containing the microorganisms i.e. RG2 material may only be used in facilities meeting the Australian Standard or OGTR requirements for PC2 facilities. Unscreened specimens should be treated as risk group 2 and therefore may also only be used in PC2 facilities.

Further information on working with infectious or potentially infectious animals can be found in PPL 2.60.13 Q-Fever Screening and Immunisation and PPL 2.60.14 Working Safely with Bats and Flying Foxes: Lyssa Virus.

6.3 Importing and working with quarantine material

The Department of Agriculture and Water Resources - Biosecurity (DAgWRB ex DAFF/AQIS) is a regulating authority that oversees Australia’s strict quarantine restrictions and prosecutes offenders in accordance with the Quarantine Act 1908 (C'th). DAgWRB provides quarantine inspection services for the arrival of international passengers, cargo, mail, animals and plants or their products into Australia, and regulates inspection and certification for a range of animal and plant products exported from Australia. DAgWRB also monitors products being imported that may pose a risk to Australia’s plant, animal and human health – including the subsequent derivatives.

DAgWRB issues permits for import and monitors compliance through auditing Quarantine Approved Premises (QAPs) - including extensive record-keeping required for all quarantine material.

Please consult PPL 2.40.10 Importing or Working with Quarantine Material for further information.

6.4 Certified facilities

The majority of GM material requires you to conduct the work in a Certified Physical Containment facility.

Certified Physical Containment (PC) ranges from levels 1 - 4 (as defined by AS/NZS: 2243.3 2010 and the Gene Technology Act 2001). The physical containment level used when working with microorganisms and genetically modified material shall be at least the appropriate level for the risk group of the microorganism.

Specific GM dealings are to be undertaken only in OGTR certified physical containment facilities overseen by the IBC. If you intend to work with genetically modified animals, insects, aquatic organisms or plants (or if any of these organisms will contain GM microorganisms) specialist PC facilities will be required. Ensure that you have the correct facility certification before submitting a GM proposal. If you are unsure of the adequacy of your facility or need to arrange for certification of your facility, contact UQ Biosafety. As part of aiding compliance, UQ Biosafety employs a grey folder system whereby relevant documents and information pertaining to compliance requirements are kept in the local PC1 or PC2 facility. When the facility is certified, the Biosafety Advisor will arrange for a grey folder to be compiled and kept with that facility.

6.4.1 Physical Containment (PC) classification

The work carried out in a laboratory or facility of a specific level shall follow procedures prescribed for that level of physical containment.

Physical Containment 1 (PC1) Facilities suitable for work with microorganisms where the hazard levels are low.

Note: Exempt dealings – the regulator has released guidance notes for the containment of Exempt dealings that are effectively equivalent to those for facilities certified by the regulator to PC1. These are described in Part 1 and 2 of Schedule 2 of the Gene Technology Regulations 2001 (C'th).

Physical Containment 2 (PC2) Facilities where practices and equipment applicable to research or diagnostic work carried out with microorganisms that are classified as risk group 2 microorganisms. A Biological Safety Cabinet class II (BSCII) will be used if working with microorganisms that are transmissible by the respiratory route or if the work produces a significant risk to humans or the environment from the production of infectious aerosol.

Physical Containment 3 (PC3) Facilities where practices and equipment applicable to research or diagnostic work carried out with microorganisms that are classified as risk group 3 microorganisms. A PC3 laboratory or facility provides additional building features and services to minimize the risk of infection to individuals, the community and the environment.

Physical Containment 4 (PC4) Facilities where practices and equipment applicable to work carried out with microorganisms that are classified as risk group 4 microorganisms.

The work carried out in a PC laboratory or facility of a specific level shall follow procedures prescribed for that level of physical containment. For example, the Gene Technology Regulations 2001 (C'th) - Schedule 3, Part 1 and 2 specifies the kinds of NLRDs suitable for PC1, PC2 and PC3 facilities. The facilities used for conducting DNIRs, must be certified by the OGTR and range from PC2-PC4 level of containment. The Regulations - Schedule 3, Part 2, 2.2 also specifies the kinds of DNIRs suitable for PC2 and PC3. The appropriate level of containment is determined by risk group classification of the wild type (non-genetically modified parent) organism outlined in AS/NZ2243.3:2010 AND the risk(s) identified for dealings with specific GMO.

6.4.2 Annual inspections

All OGTR certified facilities must be inspected annually by a suitably experienced nominee of the IBC (e.g. a Biosafety Advisor) in order to determine compliance with the conditions set out by the OGTR in the appropriate facility certification guideline. Copies of the last three years inspection reports must be kept in the facility's grey folder.

6.4.3 Working in a PC3 facility

Work involving biological material classified as Risk Group 3 must be conducted within PC3 certified facilities.

Approval is required from the IBC Secretary when the following are completed:

  • Online OHS- Biosafety training
  • PC3 training including theory and practical components
  • DNIR monitoring (if applicable)
  • Health monitoring
  • Declaration signed by each person and their supervisor

Please consult PPL 2.40.17 Working in PC3 Facility for further information.

7. Training

Persons working with biological material in PC1, PC2 or PC3 facilities are required to complete the OHS Biosafety training available online via https://learn.uq.edu.au. A UQ username and password is required to log in to the website.

Other non-UQ research partners will have training provided by their own organisation.

Contract and service staff are to refer to UQ Properties and Facilities Division or OHS Biosafety for specific training and instruction.

Additional specific training may be required prior to accessing some facilities or commencing some types of work e.g. access to PC3 facilities or animal facilities; or prior to beginning work involving lentiviral vectors or prior to working with quarantine material. Check with your local Safety Manager/Coordinator (WHSC) or building manager.

Please complete a Training Needs Analysis with your supervisor or contact UQ Biosafety.

Please consult PPL 2.40.10 Importing or Working with Quarantine Material for further information on quarantine training requirements.

8. Occupational Health

Health surveillance may be required for some work involving biological material (e.g. some work with animals, any PC3 work, some potentially hazardous biological work). If your work involves infectious material or animals that are or exudate toxins or venoms or harbour infectious agents (i.e. bats), consideration should be given to this requirement prior to commencing any work. Please contact the Occupational Health Nurse Advisor (ohs@uq.edu.au) for advice on precautions that you may or must undertake.

Vaccinations and immunisations may also be required for some work (e.g. animal work). Please consult PPL 2.60.08 Vaccinations and Immunisations.

9.Other Useful Information

9.1 Available on the OGTR website:

  • The Gene Technology Handbook
  • Guidelines on Transport, Storage and Disposal of GMOs
  • Certification of Physical Containment Facilities
  • Guideline for Accreditation of Organisations
  • Risk Analysis Framework for Licence Applications
  • Application form for Confidential Commercial Information

www.ogtr.gov.au

9.2 Other websites:

  • The DAgWRB website has guidelines, written in many languages, explaining what can and can’t be admitted into Australia. Staff are encouraged to send these links to their overseas collaborators/visitors and students prior to them sending you material and/or coming to Australia (www.daff.gov.au/biosecurity).
  • Public Health Agency of Canada - Pathogen Safety Data Sheets (PSDS) and Risk Assessments. Available online.
  • Australian/ New Zealand Standard 2243.3 2010: Safety in laboratories - Microbiological safety and containment. Available via SAI Global.

10. Contact for Additional Information

Biosafety Advisor
UQ OHS Division
Phone: 336-52365
Email: biosafety@uq.edu.au

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael

Forms

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Biosafety UQ Compulsory - Form

Biosafety UQ Compulsory - Form

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Description: 

This form must accompany any application to The University of Queensland Institutional Biosafety Sub-Committee to work with genetically modified organisms (i.e. Exempt or NLRD) on any premises owned or controlled by The University of Queensland.

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael
Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael
Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael