• Section 1 - Purpose and Context
• Section 2 - Definitions
• Section 3 - Policy Statement
• Section 4 - Procedures
• Section 5 - Guidelines

Section 1 - Purpose and Context

(1) The purpose of this policy is to:

1. minimise the risk of infection or harm to people and other organisms, or harm to the environment from the use of specimens of human (including cell lines) or animal origin that are not certified to be free of relevant human pathogens, infectious/potentially infectious animals (laboratory and non-laboratory), microorganisms or other biological material classified as Risk Group 2 and above (see AS/NZS 2243.3), infectious/potentially infectious environmental samples, biological toxins including biological material on the Defence Strategic Goods List, genetically modified organisms (includes plants, animals, microorganisms, cells and all exempt dealings), security sensitive biological agents (SSBA), quarantine biosecurity risk material, ionising radiation sources, radioactive materials and equipment, and lasers above class 2
2. protect the health and safety of people and the environment by managing risks posed by work involving hazardous biological material, and
3. ensure the University complies with relevant legislative requirements and Australian Standards.

(2) The policy applies to all University staff, students and affiliates, and extends to visitors and contractors who undertake work in laboratories.

(3) The University, as an accredited organisation under the Gene Technology Act, is required to have an Institutional Biosafety Committee. The University's committee is known as the Biosafety and Radiation Safety Committee (BRSC).

(4) This policy should be read in conjunction with the University's Cyber Security Policy; Hazard Identification, Risk Assessment and Control Procedures; Health Safety and Wellbeing Policy, Risk Management Policy, and the BRSC Terms of Reference.

Section 2 - Definitions

(5) For the purposes of this policy definitions that apply can be found in the Policy DDS Glossary, in addition to the following:

1. Adverse Event means an undesired harmful effect resulting from exposure to a harmful biological agent; or the escape, unintentional release, spill, leak or loss of a potentially harmful biological agent or a genetically modified organism outside a certified facility.
2. Biohazard means any biological agent or material that poses a risk to human health or other living organisms, or to the environment.
3. Biosafety (Biological Safety) means a collective term for procedures and practices that are followed to minimise the risk of infection and other health effects from handling or being exposed to biological materials.
4. Genetically Modified Organism (GMO):
   1. an organism that has been modified by gene technology or
   2. an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology or
   3. anything declared by the Gene Technology (GT) regulations to be a genetically modified organism, or that belongs to a class of things declared by the GT regulations to be genetically modified organisms; or any dealings in relation to a genetically modified organism; but does not include:
      1. a human being, if the human being is covered by paragraph c (i) only because the human being has undergone somatic cell gene therapy or
      2. an organism declared by the GT regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the GT regulations not to be genetically modified organisms.
5. Imported Biological Materials means biological products imported into Australia.
6. OGTR means Office of the Gene Technology Regulator (OGTR) is the Regulator, an independent statutory office holder responsible for administering the Gene Technology Act 2000.
7. OGTR Certified Facilities means physical containment facilities, certified as complying with OGTR Guidelines, where certain dealings with GMOs may be conducted.
8. Pathogenic Micro-organism means an infectious organism, usually microscopic, capable of causing disease in a host.
9. Potentially Infectious Agents means biological agents capable of causing disease in a host.
10. Security Sensitive Biological Agent (SSBA) means a biological agent that is included in the List of Security Sensitive Biological Agents published by the Commonwealth Department of Health and Aged Care - Security Sensitive Biological Agents.
11. Specimen of Human or Animal Origin means substances such as blood, tissues, organs, saliva, mucous, urine and cell lines.
12. Standard Operating Procedures (SOPs) means written instructions that outline the safest and preferred method for undertaking a particular task, work practice, process, manipulation or technique. They include all potential hazards associated with the task, the risks posed by these hazards and the appropriate control measures required to eliminate or reduce the risks. Their purpose is to ensure the safety, quality and uniformity of a task among different people. They are developed by individual Schools or Institutes and are referred to as part of BRSC application.

Section 3 - Policy Statement

(6) The University requires its staff, students, affiliates, contractors, visitors and others to adhere to this policy and to the University's Health Safety and Wellbeing Policy to maintain a safe and healthy environment by minimising the risks from biohazardous work procedures conducted in laboratories at the University's facilities.

(7) The University requires that:

1. staff, students, affiliates, visitors and others will apply to the BRSC to undertake biohazardous work procedures (as outlined in the BRSC Terms of Reference)
2. biohazardous work procedures will only be undertaken in accordance with the application as approved by the BRSC. Such applications contain those authorized to do the work, their training requirements, the nature of the biohazardous material (including GMOs), conditions pertaining to their security, transportation, storage, handling and disposal, record keeping and reference to relevant SOPs
3. no biohazardous work will be undertaken without prior approval by the BRSC
4. regular inspections and audits (at least annually) of laboratories where biohazardous work is undertaken or organisms are being quarantined are conducted. The BRSC will oversee inspections that are required by regulatory authorities. Local work areas will be responsible for conducting regular workplace inspections of all other facilities
5. at the conclusion of a project using biohazardous material, the proper procedures are followed to ensure that material is appropriately handled through either disposal or transfer of responsibility to another authorised person
6. contractors must have written approval from the Facility Manager before working in environments where a biohazardous procedure is being undertaken; and in OGTR certified facilities
7. for emergency work in OGTR certified facilities, contractors must have written permission from: the Facility Manager; or the Chair/Deputy Chairs of the BRSC; or the Division of Infrastructure and Commercial representative on the BRSC. In the event that none of these options are available, approval should be given by an appropriate responsible person
8. an adverse event must be reported to the BRSC within 24 hours by the Facility Manager
9. sensitive material or information (e.g., storage location of GMOs, biological hazards and/or chemicals) is securely stored and access to it is limited
10. Export Controls and Autonomous Sanctions Legislation: If researchers transfer certain items, technologies or information outside Australia, they may have obligations under the DTCA. Supplying, brokering or publishing items, technologies and information outside of Australia that are considered by government as 'controlled' may require a permit. Exporting 'controlled' technologies and information may also require a permit. Permits are administered by the Defence Export Controls Office (DEC) at the Department of Defence. It is important to become familiar with Australia's defence related legislation and the types of technology and items that require a permit. Failure to comply with these Acts is considered a criminal offence. For further information, refer to the Controlled Goods and Technology webpage.
11. when collaborating with international partners, researchers should take reasonable steps to consider and mitigate the threats of foreign interference and assess whether a potential contributor, employee or partner poses a risk, either reputational or security related, and  make decisions about their research, based on this assessment.  For further information, please refer to the Foreign Arrangements Scheme webpage.

(8) The University will:

1. maintain OGTR accreditation
2. maintain an appropriately constituted Institutional Biosafety Committee, as required by the Gene Technology Act 2000, that is adequately resourced for institutional monitoring
3. ensure it maintains certification of OGTR facilities and Approved Arrangement sites (previously Quarantine Approved Premises and Compliance Agreements), as defined under the Biosecurity Act 2015 (Cth)
4. restrict access to certified facilities to those persons who are inducted, adequately trained, and have approval to enter
5. ensure that all research, teaching and services at the University that involve biohazards, GMOs, SSBAs and agents requiring biosafety containment are conducted in accordance with the relevant legislation, regulations, standards, guidelines and codes
6. ensure that all persons involved in dealings with GMOs, using agents or animals containing agents classified as risk group 2 and above, SSBAs or agents requiring containment or approval under the Biosecurity Act 2015 (Cth), submit research applications, teaching protocols, progress reports and final reports to the BRSC
7. ensure BRSC reviews all applications and reports in respect of any dealings with GMOs, use of agents classified as risk group 2 and above, SSBAs or agents requiring containment or approval under the Biosecurity Act 2015 (Cth)
8. enable the BRSC to conduct monitoring inspections, at least annually, of the University's PC2 facilities in which biohazards and/or GMOs are handled to ensure compliance with the relevant legislation, regulations, standards, guidelines and codes
9. require the BRSC to report annually to the Deputy Vice-Chancellor and Vice-President, Research, Enterprise and International
10. require the BRSC to report at least annually to the OGTR in accordance with the Guidelines for Accreditation of Organisations 2012 and the Explanatory Information on the Guidelines for Accreditation of Organisations v 1.4 issued by the OGTR

(9) Where appropriate, the University will:

1. ensure biosafety is part of the organisational planning process
2. ensure resourcing is available to maintain biosafety standards
3. implement processes that require appropriate approval and monitoring of all dealings with biological hazards including reporting acquisitions, maintenance of biological inventories and project approval
4. facilitate forums for consultation and communication on biosafety matters
5. create and provide appropriate biosafety induction, instruction, training and supervision
6. provide appropriate training on Biosafety and Radiation Safety.

(10) The University will seek to ensure that:

1. industry best practice for controlling identified hazards is taken into account and, as far as reasonably practicable, introduced into the planning and delivery of University activity
2. work with biohazards is conducted in facilities that meet the relevant structural requirements to reduce the risk of unintentional infection or release of the agents
3. work conducted in containment facilities meets the relevant engineering requirements along with behavioural and administrative requirements
4. measurable objectives and targets to ensure continued improvements are established with the aim of:
   1. reducing and preventing incidents
   2. reducing non-compliance
5. effective process for resolving biosafety issues and managing risks are maintained, and
6. appropriate reporting and recording mechanisms for incidents, emergencies and near-misses are established.

Section 4 - Procedures

(11) For the BRSC application and review process, refer to the Biosafety and Radiation Safety webpage.

(12) The Facility Manager must:

1. report adverse events to the BRSC within 24 hours by contacting the Biosafety and Radiation Safety Officer (biosafetyradiation@westernsydney.edu.au)
2. maintain a GMO register which may be subjected to audit by the BRSC at its annual inspections. The GMO register must contain information including, BRSC approval number, expiry date of approval, responsible person(s), dealing type and GMO identifier, storage location or status.

(13) GMO Project Approval Procedures.

(14) GMO Amendment Procedures.

(15) BRSC Forms (application, progress/final report, and amendment request forms).

Section 5 - Guidelines

(16) Dealing with GMO.

(17) Techniques and Organisms that are not Gene Technology.

(18) Importation Requirements for Genetically Modified Organisms.

(19) Guidelines for the Transport, Storage and Disposal of GMOs.

(20) Laboratory Safety Guidelines.

(21) Radiation Management Plan (RMP).