Biosafety and Quarantine
James Cook University is committed to providing a safe workplace for staff, students and visitors to the University. The University recognises the need to protect students, staff and the environment from potential hazards associated with biological organisms or materials that may contain biological hazards.
The JCU IBC is a sub-committee to the JCU 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 Office of Gene Technology Regulation and makes recommendations relating to biosafety issues at JCU.
Hazards specifically monitored by the IBC include:
- Genetically Modified Organisms
- Materials derived from human sources
- Materials derived from animal sources in particular those with zoonotic infection, and
- Micro-organisms.
Membership
| Composition of Committee | Member and Position Title |
|---|---|
| Chairperson (Member appointed by WHSAC) | Ms Suzanne Delahunty, College Operations Manager |
Members of the Academy Division: | |
| Member 1 of 2 – College of Public Health, Medical and Veterinary Sciences | Dr Catherine Rush (or Nominee) Deputy Chair |
| Member 2 of 2 – College of Public Health, Medical and Veterinary Sciences | A/Professor Patrick Schaeffer / Dr Craig McFarlane (or Nominee) |
Member 1 of 2 - College of Medicine and Dentistry (Townsville) | Dr Alex Trollope (or Nominee) |
| Member 2 of 2 - College of Medicine and Dentistry (Cairns) | Ms Tiffany Turnour (or Nominee), Laboratory and Technical Support (Dentistry) |
| Manager, Laboratories and Technical Support | Ms Susan Kelly (or Nominee) |
| Member of the College of Science and Engineering | Dr Kelly Condon (or Nominee) |
| Senior Operations officer, Laboratories and Technical Support | Ms Amanda Norton (or Nominee) |
| Members of the Research Division: | |
| I. Member of the Molecular Ecology & Evolution Laboratory, College of Science and Engineering | Dr Nikolaos Andreakis (or Nominee) |
| II. Member of the Australian Institute of Tropical Health & Medicine - Townsville Campus | Dr Helma Antony (or Nominee) |
| III. Member of the Australian Institute of Tropical Health & Medicine - Cairns Campus | Mr Phill Walsh (or Nominee) |
| IV. Manager, Bioresources Facilities | Ms Serrin Rowarth (or Nominee) |
| Member of the Services and Resources Division, Estate Directorate | Mr Peter Cairns (or Nominee), Manager, Building Services, Estate |
| Objective Member – External Entity |
Dr Kerry Hancock Mr Shane Casson Senior HSE Partner, QUT Brisbane |
| Advisor by Invitation - Environmental Advisor (Plants and Waste) | TBA |
| Advisor by Invitation - Member from the College of Healthcare Sciences | TBA |
| Permanent Advisor - HSE Biological, Radiation and Chemical Safety Advisor | Mr Drew Kleier (or Nominee), Occupational Hygienist, Work Health and Safety Unit |
| Secretariat | Mrs Kahlia Strid (or Nominee), Divisional Support Officer, Work Health and Safety Unit |
A biosafety application is required for teaching or research projects with biological hazards. Hazards include, but are not limited to:
- Conducting activities within a physical containment facility - all users must have a biosafety application in place
- GMO
- Genetically modified microorganisms
- Genetically modified animals and plants (including knockout or transgenic mice)
- Materials derived from human source
- Any collection, handling and manipulation of material obtained from humans
- 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, in particular those with potential for causing zoonotic infection
- 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
- Synthetic toxins/biologicals
- Working with microorganisms.
Is your project relevant?
If there is uncertainty whether a project requires a biosafety application, the applicant should seek guidance by sending an email to biosafety@jcu.edu.au.
The email should include the following information:
- Applicant's name
- Contact details
- Name of supervisor
- Division
- College/Institute
- Description of the project
During the process the Divisional Biosafety Representative may be able to offer assistance.
An initial ruling will be made by an IBC member 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.
Biosafety Application
If the project is to proceed or it was obvious that an application is required, the applicant must complete a full application for submission (JCU Biosafety Application Approval). Completed applications are to be sent to biosafety@jcu.edu.au along with electronic copies of any relevant Risk Assessments.
The application should include sufficient details to enable the Biosafety representative to review your project methodologies, organisms to be used, and proposed activities incorporating any relevant risk assessments.
Please refer to the Biosafety Procedure for the sections outlined below.
Overview of obtaining approval to work with biological hazards at JCU
James Cook University Genetically Modified Organism (GMO) Dealing Application
This document (JCU GMO Dealing Application) is to be used by biosafety applicants to assist with determining the type of dealing that may be involved in their project.
This document will need to be submitted with your biosafety application and will be reviewed by the JCU Institutional Biosafety Committee.
AS/NZS 2243.3:2022 is referred to within this document. To access the document, go to the JCU Library page; Databases; Standards Australia.
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. To access this, send and email to biosafety@jcu.edu.au and include your JC number. Certifications are only issued on request.
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. Please discuss with your supervisor to complete this. The laboratory induction will be conducted by your supervisor or a laboratory manager/supervisor.
JCU maintains both Physical Containment Level 2 and Physical Containment Level 3 containment facilities that are certified by the Office of the Gene Technology Regulator (OGTR).
The facilities and procedures are maintained in accordance with:
- AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological safety and containment, which 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. The related PC certification level; the guidelines are available from the OGTR website.
| PC Rating | Hazard Level | Use/Controls | Example Microorganism | Risk Groups |
|---|---|---|---|---|
PC1 Laboratory Animal Containment Facility Plant Containment Facility Invertebrate Facility | Low | Student and undergraduate teaching laboratories. General laboratory conditions, such as sealed floors and benches. Reliant on laboratory practices to control risk. | Food grade bacteria | Risk Group 1 |
PC2 Laboratory Animal Containment Facility Plant Containment Facility Invertebrate Facility | Moderate | Research, diagnostic facilities. Where infectious aerosols could be present a biological safety cabinet will be used |
Salmonella Paratyphi A and B
Legionella sppRisk Group 2 | Risk Group 2 |
PC3 Laboratory | High | Research, diagnostic facilities. Additional controls such as airlocks, access controls, vaccination, additional training. | Australian Bat Lyssavirus | Risk Group 3 |
PC4 Laboratory | Very High | Highest level of control. Additional controls such as airlocks, access controls, vaccination, additional training, change rooms, shower facilities, and class III biological safety cabinets or fully encapsulated positive pressure suit. | Ebola | Risk Group 4 |
Biosecurity (importing) requirements are monitored by the Department of Agriculture, Water and the Environment in accordance with the Biosecurity Act 2016.
The Department issues permits for importation and monitors compliance through auditing of Biosecurity 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 such as "to be used in a PC2 animal facility".
- Import with post entry requirements including the need to use material within Approved Arrangements (AA), tracking of all materials to destruction.
Biosecurity Import Conditions
The Department of Agriculture, Water and the Environment has a Biosecurity Import Conditions (BICON) system for importing.
JCU has set up a multi user BICON account administered by the HSE 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’:
- Receiving an invite from the system administrator. Initially you would request an account from importpermit@jcu.edu.au.
- 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 and Water Resources.
Permit applications can either be paid 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.
Approved Arrangements (AA)
Approved Arrangements are the facilities registered with the Department of Agriculture, Water and the Environment that are used for work with imported materials..
The facility must meet the criteria set out in the guidelines for facility types provided by the Department of Agriculture, Water and Environment. This includes both the physical and procedural requirements. Biosecurity requirements will be in addition to those for OGTR.
Any person wishing to work with biosecurity material must undergo the Approved Arrangements for Accredited Persons (AA-AP) training for the type of facility.
Anyone working with biosecurity material must be trained in the specific permit requirements and the requirements for the facility.
Fit and Proper Person
To allow any person access to biosecurity material and the 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 biosecurity material
- Any person managing operational aspects of an Approved Arrangement
- Any person with managing responsibility for the Approved Arrangement, such as approving payment of invoice form the regulator
- A record of the test being conducted is to be maintained as evidence