Office of Research Ethics and Integrity

High-risk biologicals

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Do I need to apply for approval?

All research and teaching activities involving a high-risk biologicals requires University Biosafety Committee review, approval and monitoring.

Do not begin your project until you've received approval.

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Definition of high-risk biologicals (other than genetically modified)

The University Biosafety Committee defines high-risk biologicals as:

  1. Risk Group 3 or 4 microorganisms (whether it is done in a regulated PC3 facility or not).
  2. Any microorganisms cultured in volumes greater than 10 litres in one vessel.
  3. Risk Group 2 microorganisms which require special precautions.
  4. Infectious or potentially infectious animals (e.g. bats).
  5. Handling poisonous or venomous reptiles, insects, arthropods or fish (e.g. snakes, spiders).
  6. Biological material on the Defence Strategic Goods List (DSGL). This list includes Human pathogens (1C351), Animal pathogens (1C352), Plant pathogens (1C354) and toxins. Please also list any genetic modifications or genetic elements of any the micro-organisms listed.
  7. Security Sensitive Biological Agents (SSBA's).
  8. Imported material that is required to be handled in an Approved Arrangement (formerly Quarantine Approved Premise) (refer to the Conditions on your Permits).
  9. Permits obtained from Biosecurity Queensland including pest plants permit.

The QUT UBC definitions above are based on standards and regulations such as Appendix C of the AS/NZS 2243.1 Safety in laboratories - Planning and operational aspects as well as any material deemed appropriate by the Committee for biosafety reasons.

For information about using Genetically Modified Organism (GMOs), see our webpages on Gene Technology.

What about other biologicals not defined as high-risk?

All other biological material used at QUT are subject to the risk management processes as required by the central Health, Safety and Environment Department. Contact your local facility manager or health and safety representative for information.

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Applying to use high-risk biologicals

For research and teaching activities involving biologicals 1-7 above:

Note, for items 6 and 7 above (DSGL and SSBAs), in addition to the application form and risk assessment, other regulatory requirements will apply.

For items 8 and 9 above (Biosecurity material (Quarantine Import Permits) and Biosecurity Queensland Permits), you only need to send a copy of the permit to the Senior Biosafety Officer. You do not need to complete a high-risk biologicals application form or submit your risk assessment to the UBC for items 8 and 9.

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Submitting your application

When to submit

Applications are reviewed by the University Biosafety Committee at their meetings. Check the meeting dates and deadlines to ensure you submit in time for a specific meeting.

How to submit

Email your complete application to biosafetyethics@qut.edu.au

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Biosecurity and Approved Arrangements (formerly Quarantine)

The Department of Agriculture (formally AQIS, DAFF) sets out the conditions for import, export and containment of all goods subject to quarantine. If you import or export quarantine goods you should be aware of your responsibilities under Australian law. Researchers wishing to import goods from overseas:

  • may need an Import Permit before they can import the goods
  • may need to use and store imported goods in an Approved Arrangement (AA) (formerly Quarantine Approved Premise) as stated in the conditions on your Permit

If an AA is needed (refer to the Conditions on your Permits) you need to send a copy of the import permit to the Senior Biosafety Officer. There are further requirements relating to transport, training, record keeping and disinfectants as outlined below.

Keep in mind that if you intend to import animals or genetically modified organisms (GMOs) you will need University Animal Ethics Committee and/or University Biosafety Committee approval BEFORE you apply for an Import Permit. Find more about research/teaching involving:

Contact the Senior Biosafety Officer if you are still unsure about your requirements.

Transporting quarantine goods

Your Import Permit may allow movement to certain nominated AAs as stated in the permit conditions. You must keep records of any movement of AA material.

If your Import Permit does not allow transfer of material between AAs, you will need to submit an Application for Transfer of Quarantine Material to the Department of Agriculture and Water Resources Biologicals Imports Program.

Important: Transport of biological material by post, road, rail or air is regulated. Packaging for transport by air must be done by someone who has done a Civil Aviation Safety Authority (CASA) approved training course.

Biosecurity (Quarantine) training

Any person who handles material that requires containment in an AA must be an AA Accredited Person. AA Accreditation training is delivered over the internet. A certificate is issued upon successful completion of the training. Certificates (or copies) need to be kept in the AA.

Persons handling AA material also need to attend QUT Biosecurity (quarantine) training provided by the Senior Biosafety Officer.

Disinfectants

AAs must use Department of Agriculture and Water Resources approved disinfectants.

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Security Sensitive Biological Agents

In January 2009 a new regulatory scheme was implemented by the Department of Health to improve the security of biological agents that could potentially be used in acts of bioterrorism. The list of regulated agents includes bacterial and viral toxins and agents that pose a danger because of their ease of transmission and/or the severity of illness they cause.

The list is divided into two parts: Tier 1 agents pose the greatest risk, while Tier 2 agents are rated as less likely to pose a security risk.
List of Tier 1 and Tier 2 SSBA

The UBC performs the functions of a Management Committee as outlined in the SSBA Standards.

Anyone wishing to work with material on this list needs to apply to the UBC and submit a risk assessment form, see applying for approval.

Contact the Senior Biosafety Officer if you need more information about SSBAs.

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Defence Trade Controls Act

The Defence Trade Controls Act 2012 regulates:

  • intangible supply of technology relating to defence and strategic goods, such as supply by electronic means; and
  • brokering the supply of Defence and Strategic Goods (DSGL) goods and technology.

Australia's export control system aims to control goods and technology that can be used in chemical, biological and nuclear weapons, or military goods and technology. The purpose is not to impede trade, innovation, research or international collaboration, but rather to facilitate scrutiny.

The provisions in the Act are aimed at stopping technology that can be used in conventional and weapons of mass destruction from getting into the wrong hands. The provisions apply equally to industry and the university and research sectors.

An Export Permit is required for both tangible means (e.g. ship, aircraft, post, courier, luggage) and intangible means (e.g. email, fax, telephone, video conferencing, providing access to electronic files, or presentations).

Biological material on the Defence Strategic Goods List includes Human pathogens (1C351), Animal pathogens (1C352), Plant pathogens (1C354) and toxins and includes any genetic modifications or genetic elements of any the micro-organisms listed. There is more explanatory information for the Biotech industry on the Defence website as well as an online DSGL tool.

Personnel must contact the Senior Biosafety Officer prior to contacting the Department of Defence.

Any approval obtained for a Permit will be tabled at the next UBC meeting.

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Permits issued by Biosecurity Queensland

There are legal obligations associated with the control, supply, sale, keeping and transport of declared items regulated under Biosecurity Queensland. The Biosecurity Act 2014 allows for the following permits:

  • Prohibited Matter Permit for scientific research or controlled dealings
  • Restricted Matter Permit for biological control, commercial use or scientific research

To apply for a biosecurity certificate, complete the DAF on-line form or call their Customer Service Centre on 13 25 23. Fees may apply. If a Permit is required, the Director of OREI or UBC Chair must sign the Permit application on behalf of QUT. QUT persons with a Biosecurity Queensland permit must provide a copy of the permit to the Senior Biosafety Officer so that QUT can maintain a central register of Permits.

Some restricted items are listed below:

  • Banana plants, soil and machinery permit
  • Papaya plants
  • Cucumber, melon, pumpkin, squash and zucchini plants
  • Grape plants, soil and machinery
  • Material from the far northern biosecurity zones
  • Items from fire ant biosecurity zones
  • Items from electric ant biosecurity zones
  • Sugarcane plants, soil and machinery

For example, there are declared plants under the Land Protection (Pest and Stock Route Management) Act 2002 that are targeted for control because they have, or could have, serious economic, environmental or social impacts. It is a serious offence to introduce, keep or supply pest plants without a permit.

QUT persons with a permit must provide a copy of the permit to the Senior Biosafety Officer.

Work cannot commence prior to obtaining the appropriate approvals.

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