WHS-PRO-009 Biosafety Procedure

Intent

To document and communicate legal and other requirements for work with Biological Material.

Statutory requirements for biological safety in Queensland are regulated by the:

• Gene Technology Act (Qld), 2001
• Gene Technology Regulation, (Qld), 2002
• Biosecurity Act (Qld), 2015

Scope

This Procedure applies to all JCU workers, students, affiliates, volunteers and visitors conducting work with biological material.

Controlled Entities are required to demonstrate compliance with relevant biosafety legislation and standards.

Biological activities that are covered by this Procedure include:

• Teaching and research with genetically modified organisms (GMO);
• Teaching and research with materials derived from human sources;
• Teaching and research with materials derived from animal sources;
• Research and teaching with microorganisms;
• Teaching or research with live animals where there is risk of zoonotic infection;
• Teaching or research that involves collection of toxins from both live animals and synthesised toxins/biologicals.

This procedure also covers imported biological material which is regulated by the Department of Agriculture Water and the Environment (DAWE).

JCU has PC1, PC2 and PC3 facilities available.  A number of PC2 and PC3 facilities are registered with the Office of the Gene Technology Regulator (OGTR) and the Department of Aquaculture Water and the Environment (DAWE)  Approved Arrangements (AA).

This Procedure does not include biological safety in healthcare or research facilities that are not JCU controlled.  JCU staff and students will operate under the system in place at the facility (example Qld Health Hospital).  Where a healthcare or research facility does not have their own standards in place then these standards will apply.

Approved placements will be subject to the host organisation having relevant and adequate Policies and Procedures implemented.  In these instances, the student must adhere to the host organisation’s Policies and Procedures whist undertaking the placement.

This Procedure does not cover non-GMO plants.

Definitions

Contents

1     Duty, Obligations and Responsibilities

1.1   Facility Supervisor

1.2   Teaching Session Supervisor

1.3   Research Project Supervisor 

1.4   Individuals (JCU Workers, Students, Adjuncts and Volunteers) 

1.5   Contractors. 

2.    Overview of Obtaining Approval to Work with Biological Hazards at JCU

3.    Biosafety Control

3.1   Institutional Biosafety Committee

3.2   JCU Biosafety Application

3.2.1 Determination of Nature of Biological Hazard

3.2.2 Full Biosafety Application

3.2.3 Risk Assessment

3.3   Physical Containment Facilities

3.3.1 Summary PC Facility Levels

3.3.2 Commissioning of non OGTR, non-Biosecurity Australia, PC Facility

3.3.3 Inspection of non OGTR, non-Biosecurity Australia, PC Facility

3.4   DSGL and SSBA Materials

3.5   Biosafety Training

3.6   Equipment

3.6.1 Autoclave

3.6.2 Biosafety Cabinets

3.7   Cleaning

3.8   Clinical and Biohazardous Waste

3.9   Decontamination. 12

3.10  Decommissioning of General Physical Containment Facility

3.11  Health Management

3.11.1 Immunisation

4.    OGTR

4.1   Exempt Dealings with GMOs

4.2    Notifiable Low Risk Dealing

4.3   Licensed Dealings with GMOs Not Involving an Intentional Release

4.4   Licensed Dealings with GMOs Involving an Intentional Release

4.5   Inadvertent GMO Dealings

4.6   OGTR Certified Physical Containment Facilities

4.7   OGTR Annual Report

4.8   OGTR Annual Physical Containment Facility Inspections

4.9   Transport of GMO

4.10  Storage of GMO

4.11  Spills

4.12  GMO Decontamination

4.13  Disposal of GMO

5.     Biosecurity

5.1   Biosecurity Import Conditions

5.2   Approved Arrangements

5.3   Biosecurity Material

5.4   Biosecurity Training

5.5   Fit and Proper Person

5.6   Exporting

5.7   Approved Arrangement Accounts

6.    Biosafety Critical Incidents

7.    Packaging Diagnostic Samples

Procedure

1 Duty, Obligations and Responsibilities

Any area of JCU where Biological Material will be used must ensure that appropriate risk assessments, safe operating procedures, regulatory compliance and training are in place.

1.1 Facility Supervisor

The Facility Supervisor is responsible for ensuring:

• safe operating procedures for the equipment and safe work instructions for laboratory practices are followed and documented;
• laboratory inductions are completed;
• records are maintained for the facility;
• appropriate training is provided.

1.2 Teaching Session Supervisor

The Teaching Session Supervisor may be a member of staff or an adjunct and will be responsible for following and enforcing this Procedure (including any biosafety approvals) during an individual teaching session where biological activity occurs.

1.3 Research Project Supervisor

The Research Project Supervisor is responsible for ensuring the requirements of this Procedure have been followed for each project.

1.4 Individuals (JCU Workers, Students, Affiliates and Volunteers)

All individuals (JCU workers, students, adjuncts and volunteers) are responsible for familiarising themselves with the biological safety requirements for the specific laboratory or facility.

The approved biosafety application requirements outlined in this Procedure must be followed whilst working with Biological Material.

1.5 Contractors

Cannot conduct maintenance activities within a physical containment facility without being issued a decontamination certificate.  Depending on the scope of works the decontamination certificate may be for the whole facility or one piece of equipment.

If the contractor is conducting the decontamination, the contractor must provide evidence of decontamination processes to the Laboratory Supervisor.

2 Overview of Obtaining Approval to Work with Biological Material at JCU

Please refer to Appendix 1: Overview of Obtaining Approval to Work with Biological  Hazards at JCU .

3 Biosafety Control

The following requirements are general in nature and aimed at controlling biological safety and preventing unintended spread of microorganisms.  This Procedure should be read in conjunction with AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment which provides further information on the topics included within this Procedure.

3.1 Institutional Biosafety Committee

JCU is an Accredited Organisation certified by the OGTR.  The University is required to have an IBC in place.

The IBC is a subcommittee to the Work Health and Safety Advisory Committee (WHSAC). The current Terms of Reference for the committee are maintained by the WHS Unit.

The IBC oversees compliance of JCU with the OGTR, DAWE and makes recommendations relating to Biosafety Issues at JCU.  Hazards the IBC specifically monitor include (not limited to):

• Genetically Modified Organisms;
• Materials derived from human sources;
• Materials derived from animal sources in particular those with zoonotic infection;
• Micro-organisms.

The IBC is required to be established as part of the certification of JCU as a suitable organisation to be accredited with the OGTR to allow projects working with GMO.

The IBC must have the collective technical and scientific expertise to review and assess all the matters that are likely to be conducted by the organisation.

The following points are requirements of the IBC:

• All members are to be indemnified;
• At least one member of the IBC must be an external member;
• Conflicts of interest must be declared by members;
• The minutes of the IBC are maintained by the WHS Unit and must be retained for a minimum of 3 years from the date of each meeting;
• The IBC will determine where expertise or training is lacking and request for external members to be added to the committee and relevant training be provided to IBC members;
• Records of decisions on NLRDs, and licensed dealings must be maintained for at least 8 years after the date of assessment.

3.2 JCU Biosafety Application

A biosafety application is required for projects with Biological Hazards. Hazards include, but are not limited to:

• GMO:
  • Genetically modified microorganisms;
  • Genetically modified animals and plants;
  • Specifically work with GMO that is:
    • Notifiable low risk dealings;
    • Dealings not involving intentional release;
    • Dealings involving intentional release;
• Materials derived from human source:
  • Collecting blood;
  • Interacting with potentially infected individuals(for example, interviewing or taking biological samples);
  • Activities conducted outside of facilities being operated under infection and control requirements from Queensland Health;
• Materials derived from animal sources (eg. blood from horse, unfixed organs from cattle), in particular those with potential for causing zoonotic infection and:
  • Dealing with wild animals, such as bats (e.g. Lyssavirus);
  • Dealing with domestic animals such as horses (e.g. Hendra Virus);
  • Dealing with animals outside of Australia (e.g. rabies);
• Purposely infecting animals;
• Working with poisonous or venomous organisms;
• Toxins/biologicals;
• Working with microorganisms;
• Work with imported materials that have a condition of entry requiring use within:
  • An approved arrangement;
  • Physical containment facility (PC1 – 3).

All activities must be conducted in the appropriate facilities for the Biosafety risk taking place. For further information consult AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment.

3.2.1 Determination of Nature of Biological Hazard

If there is uncertainty whether the project requires a biosafety application, the applicant should seek guidance by sending an email to biosafety@jcu.edu.au.  The Divisional Biosafety representative may be able to offer assistance.

The email should include the following information:

• Applicants name;
• Contact details;
• Name of supervisor;
• Division;
• College/institute;
• Description of the project.

An initial ruling will be made by an IBC member (Appendix 2  IBC Membership) to determine one of the following for the project:

• Confirm that the biosafety application process is relevant, and the full biosafety application is to be completed; or
• That the biosafety application process is not relevant, and the decision will be recorded on a central register maintained on the Biosafety Drive; or
• Further information is required to make the assessment.

3.2.2 Full Biosafety Application

If the project is to proceed under a biosafety application or it was obvious that the application was required, the applicant must then complete the full application for submission (WHS-PRO-FORM-009a JCU Biosafety Application Approval form).  Completed applications are to be sent to biosafety@jcu.edu.au.

The application should include sufficient details to enable the Biosafety representative to review the project methodologies, organisms to be used and proposed activities incorporating any relevant risk assessments.

3.2.3 Risk Assessment

Research, teaching or operational work with biohazards should only be undertaken when a risk assessment has been developed and the relevant controls implemented.  A risk assessment is to be completed in RiskWare.

Section 13 of AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment is to be consulted to assign risk categories and determine applicable containment facilities that are required for microorganisms.

Human and animal clinical and diagnostic specimens are normally regarded as risk group 2 and shall be handled in a PC2 facility unless a higher risk group is indicated by the risk assessment.

Table 1: Risk Group

The risk assessment should include:

• Identification of the microorganisms and risk group or biological hazard;
• The processes and equipment to be used;
• Storage requirements and safe handling;
• Type of physical containment facility required and available eg. PC 1-4, OGTR certified, Quarantine certified;
• Containment equipment required, such as biological safety cabinets;
• Provision for handling, decontamination and disposal of wastes;
• Required PPE;
• Training and experience required;
• Health considerations including vaccinations and medical monitoring if required;
• Waste disposal

Information should be supported by full references for any documents that assisted in the completion of the application, for example journal articles, government guidelines etc.

Guidelines for Veterinary practices can be obtained from the Australian Veterinary Association website www.ava.com.au.

Determine if other requirements apply such as:

• Genetically modified organisms are regulated by the Gene Technology Act (Qld), 2001 and Gene Technology Regulation, (Qld), 2002.  These requirements will exist in addition to those for biological safety.
  • The type of dealing to be undertaken must be determined in consultation with the Biosafety representative for your Division.  The class of dealing:
    • Exempt dealing;
    • NLRD;
    • DNIR;
    • DIR;
  • Section 6 of this procedure includes the OGTR process.
• Human Ethics (https://www.jcu.edu.au/research-services/ethics-and-integrity/human-ethics);
• Animal Ethics (https://www.jcu.edu.au/research-services/ethics-and-integrity/animal-ethics);
• Use of Scheduled Drugs and Poisons (WHS-PRO-011 Drugs and Poisons Procedure);
• Use of Carcinogens (substance listed in Schedule 10 WH&S Regulation Qld) (WHS-PRO-011 Drugs and Poisons Procedure);
• Hazardous Chemicals and Dangerous Goods (WHS-PRO-010 Hazardous Chemicals Procedure);
• Radiation sources (WHS-PRO-014 Ionising Radiation Procedure);
• Permits to access geographical locations GBRMPA or National Parks;
• Use of Cytotoxic Drugs;
• Import or Export of biosecurity material.

The application will be assessed by the IBC representative who may give approval or refer the application to next meeting of the full IBC for assessment.

In considering the application the IBC may seek additional information from the applicant or external sources.

Notification of approval will be sent by email with a copy being sent to biosafety@jcu.edu.au.

Once the application is approved the project can commence.  Biosafety applications are valid for 5 years.

Any changes to the approved project activities must be referred to biosafety@jcu.edu.au and any necessary further approvals obtained before the changes are implemented.

A copy of the application is to be kept on the Biosafety corporate drive.

3.3 Physical Containment Facilities

Physical containment (PC) facilities are used to reduce or prevent release of viable organisms into the outside environment.  The facilities also control the introduction of contaminants from outside the facility.

AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment identifies the requirements for physical containment facilities 1-4. Additional requirements may be required due to work with GMO, quarantine requirements or based on the project risk assessment.

3.3.1 Summary PC Facility Levels

Table 2: PC Facility Use

* JCU does not currently have PC4 rated facilities.

3.3.2 Commissioning of non OGTR, non-Biosecurity Australia, PC Facility

When JCU intends to display the PC (1-4) rating of a facility and use the facility for the relevant risk groups, the facility must be inspected to ensure compliance with the intended physical containment rating.  PC facilities that will have OGTR or Biosecurity Australia certification will have additional criteria to be met.

PC 1 and 2 facilities can be designed and inspected by JCU personnel using the criteria from AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment. At least one member of the team is to be from the JCU IBC and have experience relevant to the type of facility.  The IBC will approve if a facility is fit for purpose.

PC3 and 4 facilities will require design and initial inspection by a suitable third party with expertise in the type of facility.  Reinspection can occur by appropriately experienced and trained JCU personnel.

Facilities PC1-4 that will be Approved Arrangements (AA) must have a third party inspection conducted by an inspector approved by the Department of Agriculture, Water and the Environment.

Records of these assessments must be kept.  Copies of these inspections are to be retained by the person controlling the lab. The facility must be inspected annually by members of the IBC and reassessed to ensure ongoing compliance.

For OGTR facilities see Section 4 of this procedure.

For DAWE Approved Arrangements (biosecurity)  see Section 5 of this procedure.

3.3.3 Inspection of non OGTR, non-Biosecurity Australia, PC Facility

The type, category and activities performed within physical containment facilities are to be reviewed and updated in the JCU Estate Directorate Space Management System.

Facility type includes the facility type (example plant, animal, invertebrate, aquaculture), physical containment type, OGTR or Approved Arrangement Certification Level.

The description of the activities conducted within the facility is from the following list:

• Work with materials derived from animal sources such as bodily fluids, tissue;
• Work with materials derived from animal sources such as bodily fluids, tissue with zoonotic risk;
• Work with materials derived from human sources such as bodily fluids, tissue;
• Work with genetically modified organisms;
• Work with genetically modified plants;
• Work with microorganisms;
• Work with live aquatic animals;
• Work with live terrestrial animals;
• Work with live toxin producing animals;
• Working with live invertebrates;
• Work with risk Group 1 Microorganisms;
• Work with risk Group 2 Microorganisms;
• Work with risk Group 3 Microorganisms;
• Work with risk Group 4 Microorganisms;
• Chemically Synthesised toxins/biologicals.

3.4 DSGL and SSBA Materials

Materials that have been identified under the Defence Strategic Goods List (DGSL) or Security Sensitive Biological Agents (SSBA) list are items identified as having potential for being weaponised.

The Defence and Strategic Goods List (DGSL) is the list that specifies goods and technology that are regulated when exported, supplied, brokered or published. A permit is required when exporting, supplying, brokering or publishing DSGL items, unless there is an exemption.

Examples can include publication of research with microorganisms and toxins.

3.5 Biosafety Training

Any person working with biological material in a PC facility and in the field must complete and pass the Biosafety Training that is available on LearnJCU.  Each business unit will have staff nominated to provide access to the biosafety training and provide a certificate of completion.

A laboratory induction is required to be completed by anyone working within a physical containment facility or laboratory.

Adequate training and instruction may also be required prior to the operation of any specific piece of equipment.

3.6 Equipment

3.6.1 Autoclave

Autoclaves are pressure vessels.  The Estate Directorate is to be consulted in regard to potential registration and inspection requirements.  If required the autoclave will be registered in the MEX system.

Operators are to be trained in the use of the autoclave.  In particular:

• Correct operation;
• Correct loading to allow decontamination of the whole load:
  • Opening of bags;
  • Positioning bags;
• Procedures for the temporary holding of material awaiting sterilisation.

The effective operation of autoclaves requires regular confirmation to ensure that sterilisation is occurring, including:

• The use of visual indicators, such as sensitive papers or tapes in each cycle;
• Monthly checks by either:
  • Biological indicators placed in several positions of the load;
  • Bacterial enzyme indicators placed in several positions of the load;
• Annual inspection and calibration of the autoclave is to be conducted by a suitably qualified person;
• Records of monthly and yearly checks/inspection must be kept.

Exhausts should be plumbed to vent external to the facility.

3.6.2 Biosafety Cabinets

Biosafety cabinets are used specifically for biological hazards; these cabinets are not the same as chemical fume cabinets.  Chemical fume cabinets shall not be used when working with infectious materials.

Anyone using a biosafety cabinet is to be trained in the operating procedures including decontamination procedures.

Any procedure that produces aerosols should be performed in a biosafety cabinet.

Biosafety cabinets are to be inspected and tested against the relevant Australian Standard for the class of cabinet:

• Before the first use;
• Annually against the relevant standard.

A label is to be attached displaying the inspection date.

Biosafety cabinets shall be decontaminated with formaldehyde gas or an equivalent before testing when they have been used for handling Risk Group 2, 3, or 4 microorganisms.

3.7 Cleaning

Laboratory staff must maintain the physical containment facility in a clean state by:

• Maintaining clear walkways;
• Cleaning up spills;
• Handling biohazardous and clinical waste;
• Cleaning and decontaminating equipment.

Contract cleaners will use a select group of inducted staff for cleaning all research laboratories and OGTR accredited facilities.  This cleaning will be limited to:

• Wet mopping of floors;
• Window cleaning;
• Removal of clearly marked uncontaminated wastes.

Dry sweeping should be avoided due to the potential to cause contamination to work in the facility.

PC2 and PC3 facilities must have dedicated cleaning equipment.

PC3 laboratories will only be cleaned by the laboratory workers.

Duties of the contract cleaners may be handled on a case by case basis (eg within the JCU entities).  Provided appropriate risk assessment and induction has been conducted.

3.8 Clinical and Biohazardous Waste

Waste streams generated from facilities with biosafety risk are to be identified and treated/disposed of appropriately (see Appendix 4 Biohazardous and clinical waste )

Clinical and biological wastes are materials that are contaminated or potentially contaminated with biological material of risk groups 1-4.  This can consist of:

• Sharps including syringes, broken glass, scalpel blades, glass pipettes.  These items should be collected in a rigid puncture proof container that can withstand pressure steam sterilisation;
• Solid samples, including plants, invertebrates, animal carcasses, bedding, potting mix, petri dishes, gloves, and PPE;
• Contaminated solids for reuse such as glassware;
• Contaminated liquids for disposal, such as buffers and culture media;
• Mixed class of material contaminated with other items such as radioactive material or hazardous chemicals:
  • Radioactive waste should not be pressure sterilised.  Waste disposal processes will be documented in the Radiation Safety Protection Plan.  Consult the relevant Division Radiation Safety Officer for information;
• Material that could contain prions should be collected for decontamination.

Waste streams may consist of:

• Uncontaminated waste:
  • (e.g. cardboard packaging) from PC1 and PC2 facilities may be disposed of in the same manner as household waste;
  • Paper towel used to dry hands after hand washing;
  • Uninfected animal carcases:
    • Uninfected mice into general waste bins;
    • Non-infectious animal bedding, fur, clippings;
• Non Clinical Biohazardous waste:
  • Waste that requires a form of decontamination or treatment but is not classed as clinical waste;
  • This would include waste with potential for animal or plant disease without risk of human infection;
  • This material would typically be placed in a clear autoclave bag and autoclaved before disposal into general waste streams:
    • Do not label as clinical or biological waste;
• Clinical Waste:
  • See Appendix 4 Biohazardous and clinical waste ;
  • Waste that has potential for infection in humans;
  • This waste must be disposed of by a regulated waste company licensed to dispose of clinical waste;
  • This would include:
    • Human blood;
    • Human tissue;
    • Sharps;
    • Culturing microorganisms that are infectious to humans;
  • Double bagged and marked as “biohazardous waste” or “clinical waste” and placed in clinical waste bins:
    • If the material is of low risk no pre-treatment (eg autoclave) is  required;
    • If high risk autoclaving prior to placing in the clinical waste bin may be conducted;
• Other requirements:
  • Waste in OGTR and Approved Arrangement  facilities will have additional requirements that are documented in the facility procedures stating specific waste disposal methods and tracking requirements (see Appendix 4 Biohazardous and clinical waste );
  • All material from PC3 laboratories must be treated as potentially contaminated.  There will be specific procedures in place for the PC3 facility.

Facility / laboratory waste contaminated with biohazardous material is to be disposed of in marked “biohazard bags” placed inside bins marked as ‘biohazardous waste’.  The facility must have procedures for storage, transport, decontamination and disposal of biohazardous waste.

Typically, decontamination will include either sterilisation by autoclaves, chemical action (germicides or disinfectants), incineration, or another method allowed by the local authorities.

Decontaminated waste shall be disposed of in accordance with relevant authority requirements.

3.9 Decontamination

Decontamination is required to remove microorganisms, and biological material before a laboratory or piece of equipment can be classed as non-contaminated and biosafety controls can be relaxed for a specified period of time to allow maintenance or other activities.

When maintenance activities are to be conducted within a laboratory on equipment that has been used for biosafety relevant activities, the equipment is to be appropriately cleaned and a Decontamination Certificate issued.

When equipment that has been used for biosafety relevant activities is to be removed from a laboratory, the equipment is to be appropriately cleaned and have a Decontamination Certificate attached.  Any laboratory specific stickers such as “quarantine” are to be removed from equipment.

When major maintenance / renovation activities occur to a physical containment facility, the facility should be inspected to ensure the intended physical containment standard has been reinstated.

All users of a facility need to be trained in the use of spill kits for biohazards. There will be some facilities (PC3) that have specific personnel who need to be notified to clean up spills.

The WHS-PRO-FORM-013c Decontamination Certificate  is issued by the laboratory /supervisor /manager (or delegate) for the space or piece of equipment.  The Decontamination Certificate can be located on the JCU Biosafety web page.

3.10 Decommissioning of General Physical Containment Facility

This process is to be completed when a laboratory is decertified.  The laboratory is to be cleaned to remove contamination by microorganisms, biological materials, GMO and chemical residue.

The interior fabric (benches, floors and other surfaces) are to be suitably cleaned. Each piece of equipment used for any relevant activity is to be cleaned and have a Decontamination Certificate attached.

All stickers and signage are to be removed.  The status of the facility is to be updated on the Estate Directorate Space Management system.

Additional requirements specific to the laboratory will need to be conducted for OGTR and Biosecurity Australia laboratories.

3.11 Health Management

If work is conducted using human pathogens of Risk Group 3 or 4, each person working in the facility may be subject to an initial medical examination, including:

• Chest X-ray where relevant, and periodic examinations;
• Baseline serum sample that is stored for future reference.

Risk Group 4 human pathogens require a system in place for reporting accidents and monitoring employee absenteeism and for the medical surveillance of illnesses that are potentially laboratory associated.

3.11.1 Immunisation

If working with human or zoonotic pathogens, or samples that may contain human or zoonotic pathogens, a risk assessment is to be performed to determine if vaccinations are required.  Consult WHS-PRO-023-Infection Control Procedure for further guidance.

4 OGTR

Certain dealings with GMOs are required to be conducted in facilities that meet and are certified as complying with both section 5.3 of this procedure and the OGTR guidelines for physical containment facilities.

Work with any GMO must be conducted in accordance with the Gene Technology Act (Qld), 2001 and Gene Technology Regulation (Qld), 2002.

Work with GMOs is prohibited unless the dealing is:

• Exempt;
• A notifiable low risk dealing;
• On the Register of GMOs;
• Licenced by the OGTR:
  • Dealing not involving intentional release (DNIR);
  • Dealing involving intentional release (DIR).

4.1 Exempt Dealings with GMOs

Exempt dealings are identified in Schedule 2, Part 1 of the Gene Technology Regulation, (Qld), 2002. The only further legislative requirement for exempt dealings is that they do not involve an intentional release of the GMO into the environment.  The dealing must still be conducted in a suitable facility for the microbiological risks.

To allow assessment of the application, the project supervisor must:

• submit a completed Biosafety Application Approval form and mark the box indicating that the project is an exempt dealing in the OGTR section; and
• ensure there is an adequate description of the project including host and vector to be used.

Email the above to the IBC Committee at biosafety@jcu.edu.au.  This will be reviewed in consultation with the relevant Biosafety Representative for the Division (See Appendix 2).

Exempt dealings are to be conducted in accordance with the OGTR “Guidance Notes for the Containment of Exempt Dealings”.

A risk assessment will be required in RiskWare addressing the hazards present in the project.

A record of exempt dealings will be recorded in a register stored on the Biosafety Corporate drive.

4.2 Notifiable Low Risk Dealing

Notifiable Low Risk Dealing (NLRD) is identified in Division 2 of the Gene Technology Regulation, (Qld), 2002. NLRD do not involve the release of a GMO into the environment.

To conduct an NLRD the project supervisor must:

• Submit a completed NLRD application form to the IBC Committee at biosafety@jcu.edu.au along with the Biosafety Application Approval form.  This will be reviewed in consultation with the relevant Biosafety Representative for the Division (See Appendix 2 – IBC Membership);
• The submission must include:
  • Description of the procedure to be undertaken including host and vector;
  • A risk assessment on Riskware covering all aspects of the project including but not limited to:
    • GMO;
    • Hazardous chemicals;
    • Radiation;
    • Biological hazards;
    • Disposal of biohazardous waste and hazardous materials;
  • Demonstration that the person has the suitable training and experience to undertake the dealing;
  • The dealing will be undertaken in an appropriate OGTR registered facility for the relevant risk group as identified in the Gene Technology Regulation, (Qld), 2002.

The NLRD acceptance or rejection must be recorded in the IBC minutes.  The NLRD must be accepted as an NLRD by the IBC. Work cannot proceed on the NLRD until approved by the IBC.

The NLRD must be added to the JCU NLRD list on the Biosafety Drive by the WHS Unit. The NLRD must have an expiry date.

4.3 Licensed Dealings with GMOs Not Involving an Intentional Release

These dealings require a license from the OGTR, but do not involve any intentional release of the GMO.  Such dealings may involve GMOs containing higher risk genes from pathogens, encode toxins, or confer a cancer causing modification or immuno-modulatory function.

These dealings are conducted in a PC2-PC4 rated OGTR certified facility.

Copies of the licences must be stored on the JCU Biosafety Corp drive.

The project owner will need to submit a JCU Biosafety Application Approval form to biosafety@jcu.edu.au.

An application form from the OGTR will need to be submitted through the IBC to the OGTR along with the supporting information.

The project cannot proceed until the OGTR has issued the licence.

4.4 Licensed Dealings with GMOs Involving an Intentional Release

These dealings require a license from the OGTR and can take up to 255 working days to receive an approval.

The project owner will need to submit a JCU Biosafety Application Approval form to biosafety@jcu.edu.au.

An OGTR application from will need to be submitted through the IBC to the OGTR along with the supporting information.

The project cannot proceed until the OGTR has issued the licence.

Copies of the licences must be kept on the JCU Biosafety Corp drive.

4.5 Inadvertent GMO Dealings

Inadvertent dealings occur primarily when a person comes into possession of a GMO due to sudden changes such as the termination of employment of the original owner of the GMO.

If a person has inadvertently come into the possession of a GMO then an inadvertent dealings application under section 40A of the Queensland Gene Technology Act 2000 (Act) is to be made.  Otherwise the person can make an application for a licence under section 40 of the Act.

The intent of inadvertent dealings licence is to allow for appropriate disposal of the GMO.

If a person finds themselves in this situation the Biosafety Representative for the relevant Division must be notified.

4.6 OGTR Certified Physical Containment Facilities

JCU maintains physical containment facilities that are accredited with the OGTR.

AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment identifies the requirements for physical containment facilities 1-4.   Facilities certified to OGTR requirement will have additional requirements that can be identified in the guidelines for each type of facility and the related PC certification level; the guidelines are available from the OGTR website (www.ogtr.gov.au).

OGTR PC1 and PC2 facilities can be designed and inspected by JCU personnel using the criteria from the OGTR for that type of facility and PC rating. OGTR facilities are inspected on an annual basis by members of the IBC.

OGTR PC3 and PC4 facilities will require design and initial inspection by a suitable third party with expertise in the type of facility.  Reinspection can occur by appropriately experienced and trained JCU personnel.

The OGTR guidelines also identify procedural requirements that are required to be in place for OGTR facilities.

Records of the certification of these facilities must be kept on the Biosafety corporate drive.

The OGTR registration sticker must be displayed at each entry to these facilities.

Access to the physical containment facilities must be controlled and staff must be specifically trained in the requirements for the particular laboratory.

All OGTR certified facilities must be listed on the register of laboratories maintained on the Biosafety Corporate drive (See Appendix 3).

4.7 OGTR Annual Report

An annual report for accredited organisations is submitted by JCU to the OGTR during the second half of each calendar year.  The OGTR will provide the template and due date for the report.

The annual report will be completed by the WHS Biological, Radiation and Chemicals Safety Advisor and reviewed by both the JCU Primary Officer for OGTR and the IBC Chairperson.

The report is then submitted to the Vice Chancellor’s Office for signing.  Once signed, the JCU Primary or Secondary Contact for OGTR submits the report to the OGTR.

4.8 OGTR Annual Physical Containment Facility Inspections

OGTR certified facilities are to be inspected on an annual basis to monitor compliance with the OGTR certification guideline for the type of facility and containment level.

Members of the IBC will conduct the inspections every year.  A consolidated list of findings will be prepared every year for corrective actions.  The corrective actions will be divided between those for the Divisions and maintenance issues for the Estate Directorate.

A record of all inspections for each year will be stored on the Biosafety corporate drive.

The results of the inspections and progress of corrective actions will be reported at the IBC meetings.

The annual inspection of the PC3 facilities is to be submitted to the OGTR by the JCU Primary or Secondary Contact for OGTR.

A copy of the annual report is to be kept on the Biosafety corporate drive.

4.9 Transport of GMO

Transport must be in accordance with the current OGTR Guidelines for Transport, Storage and Disposal of GMOs.

4.10 Storage of GMO

Storage and labelling of GMO must be in accordance with the current OGTR Guidelines for Transport, Storage and Disposal of GMOs.

All GMOs must be clearly labelled to identify the GMO.

Procedures must be in place to ensure all GMOs can be accounted for.  A record must be maintained and available if asked for by the Regulator.

Access to the GMOs must be restricted.

4.11 Spills

Documented procedures must be in place for facilities and projects to decontaminate any spills involving GMOs.

Loss of containment outside of a facility must be reported to the OGTR.  An incident must also be lodged in RiskWare.

4.12 GMO Decontamination

Decontamination must be undertaken in accordance with the OGTR Guidelines for the Transport, Storage and disposal of GMOs.  Specific procedures must be in place for each facility.

Equipment contaminated with, or suspected to be contaminated with, GMOs must be decontaminated before being removed from the facility, except if being transported for the purpose of decontamination in accordance with the OGTR Guidelines for the Transport, Storage and Disposal of GMOs.

All decontamination procedures must be undertaken by trained personnel.

Work benches and surfaces where a procedure involving GMOs has taken place must be decontaminated when the dealings are completed.  Equipment directly used in procedures involving GMOs and equipment suspected to be contaminated must be decontaminated when the dealings are completed.

4.13 Disposal of GMO

Storage and labelling of GMO must be in accordance with the current OGTR guideline for Disposal of GMOs.  The method of disposal and decontamination is to be identified in the project risk assessment.

5 Biosecurity

Biosecurity requirements are monitored by the Department of Agriculture Water and Environment in accordance with the Queensland Biosecurity Act 2014.

The Department issues permits for importation and monitors compliance through auditing of  Approved Arrangements (AA).

Import permits impose the requirements relating to the specific application. The requirements of a permit must be met in full.

Import permit requirements can range from:

• Initial inspection at the point of entry.  In some cases there are no further requirements;
• Import with post entry requirements:
  • Use of the item within a facility of the correct containment type and level (example physical containment 2 laboratory);
  • Use of the item within a specific Approved Arrangement.  When these conditions are imposed the following will be conditions stated:
    • Obtain a Quarantine Entry Number from customs;
    • Tracking of use, culturing and disposal;
    • Access by only persons that have completed the relevant training (Guardian or equivalent).

5.1 Biosecurity Import Conditions

The Department of Agriculture, Water and Environment has a Biosecurity Import Conditions (BICON) system for importing.

James Cook University has set up a multi user BICON account administered by the Workplace Health and Safety Unit.

Anyone planning on submitting import permit applications will need to register as a ‘user’ on the system.  There are two ways to become a ‘user’:

1. Receiving an invite from the system administrator.  Initially you would request an account from importpermit@jcu.edu.au;
2. When applying in the BICON system selecting the ‘account type’ as joining an existing ‘multi user account’, and selecting James Cook University.

Once you have a user account, applications can be submitted to the Department of Agriculture, Water and Environment.

Permit applications can either be paid for by credit card or a tax invoice can be generated from the system.  Be aware that when an invoice is generated the assessment process will not start until after the invoice is paid.

Any permits in the previous ICON system will not convert over to BICON, and will eventually expire under the old system.

Further information can be found at the following link: “http://www.agriculture.gov.au/import/bicon”.

5.2 Approved Arrangements

Approved Arrangements are the facilities registered with the Department of Agriculture, Water and Environment.

The facility must meet the criteria set out in the guidelines for facility types provided from the Department of Agriculture, Water and Environment.  This includes both the physical and procedural requirements (http://www.agriculture.gov.au/import).  Quarantine requirements will be in addition or independent to those for OGTR.

Each facility is inspected and approved by the Department of Agriculture, Water and Environment.  Records of the certification and inspections are to be retained by the laboratory manager.

The AA registration stickers must be displayed at each entry to the facility. The list of JCU Approved Arrangements is provided in Appendix 3  OGTR & Quarantine certified laboratories.

Facilities are to remain locked when personnel are not in attendance.

The facilities are to be inspected annually by the JCU Institutional Biosafety Committee.

To decommission AAs, the biosecurity material must be transferred, stored or destroyed as per permit conditions and the facility must be fully decontaminated. The Department of Agriculture, Water and Environment will also need to conduct a final inspection.

5.3 Biosecurity Material

Material that has on-going biosecurity requirements will have a Quarantine Entry Number (QEN) assigned and the import permit will state the AA number where the material must be stored and used.

JCU will use the import permit number and a unique sample identifier to track the use of the material including splitting of samples, and disposal.

Biosecurity material is to be kept physically separated from other non-biosecurity material.  The material must be labelled with the QEN and name of the material owner.

The material can only be transferred between AAs listed on the specific permit. A new application must be lodged with the Department of Agriculture, Water and Environment to add AAs.

5.4 Biosecurity Training

Any person wishing to work with quarantine material must undergo the “Quarantine Approved Arrangement for Accredited Persons” (QAA-AP) training for the type of facility.

Anyone working with quarantine material must be trained in the specific permit requirements and the requirements for the facility.

5.5 Fit and Proper Person

To allow any person access to biosecurity material the  WHS-PRO-FORM-009b Approved Arrangements, a “Fit and Proper Person” test must be successfully passed.  The test is to be applied to:

• Any person working with the material;
• Any person who can access quarantine material;
• Any person managing operational aspects of an Approved Arrangement;
• Any person with managing responsibility for the Approved Arrangement, such as approving payments of invoices from the regulator.

A record of the test being conducted is to be maintained as evidence.

If a person answers yes to a question, it does not necessarily mean they will be excluded from the facility.  Follow up will be required to determine the outcome with the:

• Persons responsible for management of the laboratory; and
• The WHS Biological, Radiation and Chemicals Safety Advisor.

5.6 Exporting

If exporting material the requirements of both the Department of Agriculture, Water and the Environment  and the intended receiving country must be met.

Correct shipping and packaging of the material will need to be in place.

5.7 Approved Arrangement Accounts

A central register of approved arrangements is retained by the JCU WHS Unit.  The listing includes account codes to be charged for Approved Arrangement compliance costs.

The Approved Arrangement list and account codes is provided to JCU Procurement to allow processing of invoices from the Regulator.

6 Biosafety Critical Incidents

Biosafety critical incidents are those that could have high risk consequences for health, the environment or public perception.

Examples of biosafety critical incidents could include:

• Diagnosis or suspected risk group 3 or 4 microorganisms such as Ebola or Anthrax;
• Diagnosis or suspected zoonotic diseases such as Hendra or Lyssavirus virus;
• Theft of biosecurity sensitive material.

Where a situation is thought to have potential to escalate into an emergency or critical incident, the college or institute management are to be informed.  The WHS Unit is also to be notified.  Initial discussions will be held to determine the level of risk and the immediate actions.

A staff member with relevant technical knowledge of the IBC should be consulted during any biosafety emergency to assist in determining the probability and level of risk.

A critical incident can only be declared by the Vice-Chancellor or the Chief Incident Coordinator (JCU Chief of Staff).

The following may be considered:

• The James Cook University Critical Incident Policy in particular notification of the Chief Coordinator (JCU Chief of Staff);
• Risk assessment:
  • Probability of the actual biosafety hazard being present;
  • Screening tests where a high risk disease is not expected to be confirmed will warrant a different level of response to a diagnostic test where the disease is suspected to be confirmed;
  • Consequence of the biosafety hazard;
• Key Divisional contacts:
  • Including out of normal business hours contacts;
• Quarantine of the:
  • Facility;
  • Animal;
  • Person;
• Legislative requirements that may be required to notify government agencies such as OGTR, Queensland Health or Department of Agriculture, Water and Environment (Biosecurity);
• Arranging for the collection and shipping of diagnostic samples;
• Immediate actions to take:
  • Quarantine;
  • Cleaning;
  • PPE;
  • Identifying locations, people, animals that could be affected.

7 Packaging Diagnostic Samples

Biological material/samples that are being transported need to be assessed against the relevant requirements for the mode of transport (road, rail, air or sea) and the class of sample.

Classes of dangerous goods that are relevant under the IATA Dangerous Goods Regulation include:

• Class 6.2 Dangerous Goods, infectious substances:
  • “Category A (UN2814)”, could cause permanent disability, or fatal disease to humans or animals.  This could include diagnostic samples for Hendra, or samples where a pathogen is known to be present;
  • “Category B (UN3373)”, are substances that are suspected or are known to contain less virulent pathogens;
• Exempt due to minimal likelihood of pathogens and the pathogens are Risk Group 1 (AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment).  Exempt parcels do still require certain packaging and markings as identified in the IATA Dangerous Goods Regulation;
• Toxins from plants, animals, or microorganisms may be classed under 6.1, Dangerous Goods, Toxic Substances;
• Class 9 Dangerous Goods, Miscellaneous Substances for samples packed with dry ice.  Exempt quantities exist and exempt quantity packing and marking apply.

In general, the packing and shipping will require:

• Determination of the class of Dangerous Good, if any;
• Packing by a method relevant for the class of dangerous good or exempt category;
• A person who has completed the relevant dangerous goods packing course e.g. such as CASA/IATA approved packager.  To package, label and prepare documents.

Related documents and legislation

AS 2252.4-2010 Controlled environments - Biological safety cabinets Classes I and II - Installation and use (BS 5726:2005, MOD)

AS/NZS 2243.3:2010 Safety in laboratories - Microbiological safety and containment

AS 2252.1-2002 Biological safety cabinets - Biological safety cabinets (Class I) for personnel and environment protection

Biosecurity Act (Qld) 2014

Biosecurity Regulation 2016

Department of Agriculture and Fisheries (Biosecurity) (www.daf.qld.gov.au)

Gene Technology Act (Qld) 2016

Guideline Clinical and related waste, ESR/2015/1571, version 1.01 26 March 2015

Licence application form for GMO dealings involving intentional release.

Licence application form for GMO dealings not involving intentional release

Office of the Gene Technology Regulator www.ogtr.gov.au

OGTR guidelines for Transport, Storage and Disposal of GMOs

Online Application form for Notifiable Low Risk Dealing (NLRD)

Appendices and related forms

Appendix 1: Overview of Obtaining Approval to Work with Biological Hazards at JCU

Appendix 2: JCU Biosafety Representatives and Institutional Biosafety Committee (IBC)

Appendix 3: OGTR & Quarantine Certified Laboratories

Appendix 4: Biohazardous and Clinical Waste

WHS-PRO-FORM-009a JCU Biosafety Application Approval form

WHS-PRO-FORM-009b Template “Approved Arrangements” “Fit and Proper Person” Induction Form

WHS-PRO-INFO-009c Biosafety at JCU Information Sheet

Administration

NOTE: Printed copies of this procedure are uncontrolled, and currency can only be assured at the time of printing.

Approval Details

Revision History