Biosafety and Quarantine

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

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.
• 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, 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.

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.

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’:

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 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