³ÉÈË´óƬ

Each person working with GMOs or working in certified physical containment facilities has a responsibility to:

• understand and comply with the relevant requirements for working with GMOs and within a physical containment facility
• undertake anyÌýtraining required by the School, IBC or OGTR and acknowledge that training in writing
• understand the risks and management of any hazards for the particular GMOs with which they work
• participate in a risk assessment process with their Supervisor/Principal Investigator for all new research work
• be familiar with any stipulations or conditions of the approvals for the GMO work they are undertaking
• advise their Supervisor and the Facility Manager immediately of any accidents, injuries or illnesses associated with GMO dealings and submit UniSafe reports where required
• advise their Supervisor and the Facility Manager immediately of any unintentional releases, losses, theft or unauthorised access or use of GMOs
• advise the Facility Manager of any building or equipment damage occurring or noted in a certified containment facility
• ensure that storage, transport, and disposal of GMOs is in accordance with the IBC and OGTR's requirements
• be familiar with Health, Safety and Wellbeing (HSW) responsibilities, and know the emergency procedures for spills and any emergency procedures particular to their work
• ensure preventative measures are instigated to minimise potential risks in the facility
• be familiar withÌýand follow the particular operating procedures relevant to their work and the equipment that they utilise

The Facility Manager has a responsibility to ensure that:

• the certified facility is maintained as per the requirements of the guidelines for the certification of physical containment facilities and that they actively identify and report non-compliance to the IBC
• only authorised personnel have access to the certified facility
• appropriate facility-specific induction is provided for all personnel before they commence working in a certified facility and that ongoing training isÌýprovided
• all unauthorised personnel (e.g maintenance contractors, lab visitors) have received a contractor's or visitor's induction prior to the commencement of work or entry to a certified facility
• all personnel are aware of the requirement to follow standard operating procedures, safety, emergency, equipment and maintenance procedures for the certified facility
• adequate personal protective equipment is supplied
• storage, transport, and disposal arrangements for regulated biologicals are in accordance with the IBC and OGTR requirements (e.g. freezer break-down procedures, bin collection and transport, PPE laundering)
• a register is maintained of all personnel authorised to access the certified facility and their associated Record of Training and induction records
• they report to the IBC any information asked of them by the IBC (or their Head of School/Department on behalf of the IBC)
• the IBC is notified prior to commencement of any planned maintenance, refurbishment, repair or building activities involving infrastructure within or servicing the certified facility
• facilities, equipment, or work areas are decontaminated prior to any maintenance, refurbishment, repair or building activities - consult with the IBC to determine extent of decontamination required prior to works commencing
• work with GMOs is not undertaken whilst any maintenance, refurbishment, repair or building activities are undertaken in a certified facility
• the IBC is advised immediately of any accidents, injuries or illnesses associated with GMO dealings, and the UniSafe reports are submitted where required.
• the IBC is advised immediately of any unintentional releases, losses, theft or unauthorised access or use of GMOs
• that the IBC's representatives (Research Compliance Officers) and OGTR Inspectors are granted access to the certified facility for the purpose of undertaking audits, inspections and assisting with incident response
• all personnel are provided with adequate training emergency procedures including for spills, fires and explosions before they commence working in a certified facility

Each Principal Investigator and Supervisor has a responsibility to:

• ensure that their GMO dealings, or those of their student(s), are appropriately authorised
• ensure that all approved GMO work does not deviate from the terms of the original approval
• ensure that personnel are aware of any stipulations or conditions of licenses and that these are complied with
• ensure that safe working procedures are understood by staff and students and are enforced
• undertake risk assessments for all new research work and update risk assessments and controls in response to evolving research requirements, incidents, accidents or newly identified hazards
• ensure that all staff and students undertaking work in relation to the GMO dealing are appropriately trained in the procedures they are undertaking and the associated risk controls
• enforce certified facility behavioural requirements for staff and students under your supervision
• maintain a register of all GMOs stored or in use under each approved dealing
• report to the IBC any information asked of them by the IBC (or their Head of School/Department on behalf of the IBC)
• advise the IBC and Facility Manager immediately of any accidents, injuries, or illness associated with dealings involving use of GMOs, and submit UniSafe reports where required
• advise the IBC and Facility Manager immediately of any unintentional release,Ìýloss, theft or unauthorised access or use of GMOs
• advise the IBC of any changes to the approved dealing, including changed to personnel and facilitiesÌýand to notify the IBC upon the completion of the dealing
• ensure applications are submitted to renew expiring dealings in a timely manner, and prior to expiry
• ensure that all work is undertaken in a containment facility of the right class and level for the dealings being contained

The Head of School or Department has a responsibility to ensure:

• personnel within their School or Department are aware of and undertake their responsibilities in relation to compliance with relevant legislation, guidelines and standards relating to gene technology, GMOs and certified facilities
• they are aware of all GMO work being undertaken in their School or Department
• effective practices are in operation to comply with relevant legislation and guidelines
• that the School/Department appropriately resources certified facilities to allow them to be maintained in accordance with relevant OGTR requirements
• Principal Investigators and Facility Managers are adequately supported to undertake appropriate training to enable them to execute their responsibilities with regards to gene technology and certified facility obligations
• information required by the IBC for the purposes of reporting to the OGTR or University is provided
• any breaches or acts of non-compliance by personnel are reported to the IBCÌý
• that the IBC is advised immediately of any accidents, injuries or illnesses associated with GMO dealings and subsequently provide a report on the investigation of such incidents.
• that the IBC is advised immediately of any unintentional releases, losses, theft or unauthorised access or use of GMOs

The Executive Dean has a responsibility to ensure:

• Heads of Schools/Departments and personnel within their Faculty are aware of and undertake their responsibilities in relation to compliance with the legislation and guidelines relating to GMOs and certified facilities

The Deputy Vice-Chancellor (Research) on behalf of the Vice-Chancellor is responsible for:

• authorising applications for licenced dealings and requests for certification of physical containment facilities on behalf of the organisation
• ensuring adequate staffing and resources are available to maintain quality assurance systems for compliance with the legislation and guidelines
• ensuring a competent, indemnified Institutional Biosafety Committee (IBC) is part of the quality assurance system.

If you are working with GMOs and/or undertaking research (of any kind) in a certified physical containment facility then you are required to comply with the responsibilities for 'all personnel' above. You must have the permission of the Facility Manager to access a certified facility.

If you are undertaking maintenance or other non-research related activities (e.g participating in a tour) in a certified facility you should:

• report to the Facility Manager prior to entering the facility
• sign a contractor's or visitor's induction for the certified facility
• comply with any instructions or training provided by the Facility Manager
• comply with instructions or warnings on any signage within the facility.
• not touch research materials or equipment in the facility unless directly authorised to do so

If you are required to enter a certified facility in response to an emergency, please attempt to contact the Facility Manager or a Principal Investigator before entering the facility or before 'touching anything'.

Do not attempt to clean up a spill or other 'mess' in a certified facility - wait for the Facility Manager.

The OGTR has extensive powers to allow monitoring and enforcement of the legislation.

The legislation establishes offences for unauthorised dealings with a GMO.

If a researcher knowingly undertakes GMO work for which a licence or approval is required and the researcher does not have one, the person concerned is not covered by University indemnity.

For all GMO work, personnel are within their rights to ask for a copy of the approval and should they be required to work in a way which could breach the approval, the GT Act, or in a manner that is unsafe, they should decline, discuss the matter with the Principal Investigator and/or report the matter immediately to the Head of School or Department.

The penalties for unauthorised dealings with GMOs are:

• $55,000 for an individual and $275,000 for a body corporate or 2 years imprisonment;
• if the offence is an aggravated offence (that is, one that causes significant damage, or is likely to cause significant damage, to the health and safety of people or the environment) – $220,000 for an individual and $1.1 million for a body corporate or 5 years imprisonment;
• for strict liability offences - $22,000 penalty units in the case of an aggravated offence and $5,500 penalty units in any other case.

The legislation also establishes offences for:

• breach of conditions of a licence;
• breach of conditions for NLRDs;
• and breach of conditions on the GMO Register.

The University could also face penalties arising from an investigator's non-compliance, including considerable adverse public attention or loss of 'Accredited Organisation' status resulting in a ban for all researchers in the institution from undertaking further work in gene technology.

The University's Institutional Biosafety Committee assists the ³ÉÈË´óƬ to comply with the relevant legislation and does this by:

• providing advice to staff and students about the Act, Regulations and Guidelines;
• determining appropriate policies, strategies and procedures;
• assessment and review of proposed gene technology dealings including determination of containment levels for the work proposed and review of qualifications and experience of persons involved;
• ensuring that appropriate registers are maintained of all gene technology dealings, genetically modified organisms, personnel who have undertaken training, incidents;
• maintaining a list of certified facilities and carrying out annual inspections;
• providing an annual report to the OGTR and preparing other reports, submissions or correspondence as required;
• liaising with the OGTR regarding every aspect of accreditation, compliance and licensing;
• providing training for staff and students involved with gene technologyÌýresearch and teaching.