• Section 1 - Purpose and Scope
• Context
• Section 2 - Process and Key Controls
• Section 3 - Key Requirements
• Training and Risk Management
• Approval Process
• Compliance with Hazardous Risk Biological (HRB) Approvals
• Reporting Breaches
• Section 4 - Roles, Responsibilities and Accountabilities
• Institutional Biosafety Committee (IBC)
• Institutional Biosafety Sub-Committee (IBSC)
• Chief Investigators
• Heads of Organisational Units
• UQ Workers
• Health, Safety and Wellness Division
• Section 5 - Monitoring, Review and Assurance
• Non-compliance
• Section 6 - Recording and Reporting
• Section 7 - Appendix
• Definitions, Terms, Acronyms

Section 1 - Purpose and Scope

(1) This Procedure outlines requirements at The University of Queensland (UQ) for conducting work with hazardous risk biological material. The definition of “hazardous risk biological material” for the purposes of this Procedure is provided in the Appendix.

(2) Hazardous risk biological material has the potential to cause harm to humans, animals, plants and the environment if not correctly contained and handled during research activities. As such, any work with hazardous risk biological material in any premises owned or controlled by UQ must be managed according to this Procedure.

(3) This Procedure applies to all UQ workers – including staff, students, visitors, and volunteers – working with hazardous risk biological material at UQ. For the purposes of this Procedure, the definition of UQ workers is broad to support UQ’s responsibilities under the Work Health and Safety Act 2011. The definition of UQ workers is provided in the Appendix.

(4) This Procedure supports and should be read in conjunction with UQ’s Biosafety Policy and other relevant procedures (e.g. Low Risk Genetically Modified Dealings Procedure, if the material is also genetically modified).

Context

(5) All workers at UQ have a duty under the Work Health and Safety Act 2011 to ensure that the risk of exposure to any hazardous material is eliminated or minimised as far as possible. This includes prevention of exposure of people or contamination of the environment with hazardous risk biological material.

Section 2 - Process and Key Controls

(6) UQ workers must comply with the following measures when working with hazardous risk biological material at UQ:

1. UQ’s Institutional Biosafety Committee (IBC) delegates authority to assess and approved hazardous risk biological material dealings to the University’s Institutional Biosafety Sub-Committee (IBSC).
2. Before commencing work, UQ workers must follow appropriate risk management procedures and be properly trained (UQ’s online Biosafety training and specific training determined by the supervisor) and assessed competent by their supervisor to work with hazardous risk biological material.
3. Undergraduate students, volunteers and visitors who have not undertaken the University’s biosafety training modules and been deemed competent by their supervisor must be closely supervised at all times by a UQ worker authorised to undertake the work with hazardous risk biological material.
4. Work with hazardous risk biological material must not commence without prior approval from UQ IBSC to ensure the proposal complies with the relevant classification criteria (known as “Hazardous Risk Biological (HRB) Approvals”).
5. Chief Investigators are primarily responsible for the oversight of HRB Approvals at UQ, including the application process and ongoing management of the approved activity.
6. Work with hazardous risk biological material at UQ must be performed in a level 2 or higher certified physical containment facility (PC2 or PC3), as appropriate to the risk group classification of the material.

Section 3 - Key Requirements

Training and Risk Management

(7) Before conducting any work with hazardous risk biological material, UQ workers must:

1. undertake the appropriate induction training as required (refer to the staff health and safety training and induction website and the Induction and Training Needs Assessment Checklist);
2. complete a risk assessment(s) and familiarisation with any standard operating procedures;
3. obtain approval from the UQ IBSC (refer to ‘Approval Process’ provisions of this Procedure); and
4. comply with the conditions stipulated in the IBC's approval of the work.

Approval Process

(8) Work with hazardous risk biological material is not permitted at UQ without prior approval from the UQ IBSC. Applications to work with hazardous risk biological material must be made to the IBSC by the Chief Investigator using the Lab Activity Application Register in UQSafe.

(9) The Chief Investigator must provide sufficient information within the application to allow the IBSC to determine whether the proposed dealing meets the relevant classification criteria.

(10) All approved work with hazardous risk biological material must comply with any conditions stipulated in the IBSC's HRB approval of the work.

Compliance with Hazardous Risk Biological (HRB) Approvals

(11) Chief Investigators and UQ workers are responsible for monitoring all aspects of work authorised under a HRB Approval. In conducting work with hazardous risk biological material, Chief Investigators must:

1. ensure that the work complies with the conditions of the IBSC's approval and is conducted in a certified physical containment facility appropriate for the risk group of the material being used (i.e. PC2 for risk group 2 material, PC3 for risk group 3 material);
2. regularly monitor and review the work until the HRB Approval is closed by the Chief Investigator, a UQ Biosafety Advisor or the IBSC;
3. ensure correct storage of all hazardous risk biological material or infectious microorganisms;
4. ensure correct disposal of all hazardous risk biological material or infectious microorganisms and associated waste; and
5. inform UQ’s Biosafety Advisors if movement to another facility not listed on the approval, is required.

(12) In order to close an HRB Approval, all materials must be either been transferred to another approval, reviewed and assigned a new IBC number for continuation following review (if required), or destroyed.

Reporting Breaches

(13) Any actual or potential breaches of conditions associated with the use, storage or handling of hazardous risk biological material must be reported as soon as practicable to UQ Biosafety Advisors (biosafety@uq.edu.au).

Section 4 - Roles, Responsibilities and Accountabilities

Institutional Biosafety Committee (IBC)

(14) The IBC delegates the assessment of Hazardous Risk Biological Dealings to the IBSC.

Institutional Biosafety Sub-Committee (IBSC)

(15) The IBSC will undertake duties in accordance with its Terms of Reference and the Biosafety Policy. The IBSC's responsibilities include:

1. assessment and approval of applications for work with hazardous risk biological material;
2. assisting Chief Investigators determine classification of work covered under this Procedure; and
3. providing UQ workers with education, information and support to enable them to understand their biosafety compliance obligations at UQ.

Chief Investigators

(16) Chief Investigators are responsible for the ongoing monitoring, management and oversight of work with hazardous risk biological material, and must ensure:

1. activities are conducted in appropriate facilities and that the facilities are tested, serviced and maintained to comply with relevant equipment or IBC/IBSC requirements;
2. a HRB Approval from the UQ IBSC is in place prior to commencing work;
3. records are maintained in accordance with facility certification or IBSC approval requirements;
4. UQ workers that handle, store or use high risk biological material:
   1. are trained in accordance with UQ IBSC requirements; and
   2. comply with all conditions of approval from the IBSC and/or for the use of the containment facility, including supervision of any classes of person not authorised by the IBSC to work unsupervised with the material (including undergraduate students, visitors and volunteers);
5. HRB Approvals are reviewed and extended or closed where necessary; and
6. breaches or non-compliances of approval conditions are reported to the UQ Biosafety Advisors as soon as practicable.

Heads of Organisational Units

(17) Heads of Organisational Units that undertake work with hazardous risk biological material must work with Chief Investigators to ensure containment facilities are compliant with OGTR or IBC requirements, including:

1. facilities appropriate for the type of work are available and maintained in compliance with the relevant legislative requirements; and
2. any work with material considered hazardous risk biological material is conducted in compliance with requirements detailed in this Procedure, facility certification guidelines or IBSC approvals.

UQ Workers

(18) All UQ workers working with hazardous risk biological material at UQ must comply with this Procedure, understand and comply with any additional IBC requirements, and ensure they are:

1. following the requirements for the facility being worked in (i.e. complete relevant training, comply with PPE requirements etc.); and
2. aware of any approvals and risk assessments that are in place for the work they are conducting.

(19) UQ workers handling, using or storing hazardous risk biological material at locations external to UQ, must comply with the local procedures and requirements of the external organisation.

Health, Safety and Wellness Division

(20) The Health, Safety and Wellness Division is responsible for:

1. providing UQ workers with advice and support regarding requirements for working with hazardous risk biological material and relevant regulatory compliance obligations at UQ; and
2. assessing whether Organisational Units and UQ workers can demonstrate compliance with this Procedure and that any compliance issues identified are rectified in a timely manner.

(21) Biosafety Advisors within the Health, Safety and Wellness Division are responsible for:

1. advising workers about specific biosafety matters affecting UQ, including workplace safety obligations and regulatory compliance; and
2. reporting to or advising UQ’s IBSC on hazardous risk biological material as required.

Section 5 - Monitoring, Review and Assurance

(22) UQ Biosafety Advisors will provide ongoing monitoring and review of UQ’s biosafety systems and controls on behalf of the IBC, including:

1. annual audits and inspections of OGTR or IBC certified facilities where work with hazardous risk biological material is undertaken;
2. renewal of any associated facility certifications; and
3. renewal of any associated GM dealings or licences.

(23) UQ Biosafety Advisors will review this Procedure as required to ensure it remains current and accurately reflects regulatory requirements.

Non-compliance

(24) UQ workers who do not comply with this Procedure may be subject to corrective actions from the IBC, which may include suspension of work if conditions are not met. Appropriate action may also be instigated by the UQ worker’s line management.

(25) UQ may be subject to corrective actions or notices issued by a Regulatory body to suspend work that does not comply with regulatory requirements if the work is conducted in OGTR certified facilities and/or an Approved Arrangement, or if there are associated genetically modified (GM) dealings.

Section 6 - Recording and Reporting

(26) Chief Investigators must ensure that the record-keeping requirements of approved HRB Approvals are met in accordance with UQ’s Research Data Management Policy.

(27) UQ Biosafety Advisors will report outcomes of audits of OGTR or IBC certified facilities where work with hazardous risk biological material is undertaken to the IBC on a regular basis. The IBC will report any non-compliances or potential breaches to the relevant Deputy Vice-Chancellor, Executive Dean or Institute Director and line management for the relevant area.

(28) The Director, Health, Safety and Wellness is responsible for reporting any matters required by the Act or Regulations, approvals or licences to the OGTR.

Section 7 - Appendix

Definitions, Terms, Acronyms