Your Responsibilities

All persons working with regulated biologicals and those working in containment facilities have obligations and responsibilities to comply with regulatory and institutional requirements.

Unless otherwise specified, reference to ‘regulated biologicals’ in the responsibilities of each section below applies to work involving all the following:

  • gene technology and genetically modified organisms (GMOs).
  • imported biological goods subject to biosecurity control (GSTBC).
  • risk group (RG) 2 (or higher) microorganisms and samples or organisms known to contain these.

And reference to ‘containment facilities’ applies to all the following containment facility types:

  • Office of the Gene Technology Regulator (OGTR) certified facilities.
  • Department of Agriculture, Fisheries and Forestry (DAFF) biosecurity facilities (Approved Arrangements).
  • Institutional Biosafety Committee (IBC)-registered microbiological facilities.
  • All personnel

    Each person working with regulated biologicals or working in containment facilities has a responsibility to:

    • understand and comply with the relevant codes of behaviour for working with regulated biologicals and within containment facilities.
    • undertake any training required by the School, IBC, OGTR or DAFF and acknowledge that training in writing.
    • understand the risks and management of any hazards for the particular regulated biologicals 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 or permits for the work they are undertaking.
    • advise their Supervisor and the Facility Manager immediately of any accidents, injuries or illnesses associated with dealings, projects or permits involving use of regulated biologicals, and submit UniSafe reports where required.
    • advise their Supervisor and the Facility Manager immediately of any unintentional releases, loss, theft or unauthorised access or use of regulated biologicals.
    • advise the Facility Manager of any building or equipment damage occurring or noted in a containment facility
    • ensure preventative measures are instigated to minimise potential risks in the facility.
    • ensure that the storage, transport and disposal of regulated biologicals is in accordance with the IBC, OGTR and/or DAFF 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.
    • be familiar with and follow the particular standard operating procedures relevant to their work, their facilities, and the equipment that they utilise.
  • Facility manager

    The Facility Manager has a responsibility to ensure that:

    • containment facilities are maintained as per the requirements of relevant guidelines and standards and that they actively identify and report non-compliances to the IBC.
    • only authorised personnel have access to the containment facility.
    • appropriate facility-specific induction is provided for all personnel before they commence working in a containment facility and that ongoing training is provided.
    • 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 containment facility.
    • adequate personal protective equipment is supplied.
    • storage, transport and disposal arrangements for regulated biologicals are in accordance with the IBC, OGTR and/or DAFF requirements (e.g., freezer break-down procedures, bin collection and transport, PPE laundering, etc.).
    • a register is maintained of all personnel authorised to access the certified facility and of their associated 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 containment 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 regulated biologicals is not undertaken whilst any maintenance, refurbishment, repair or building activities are undertaken in containment facilities.
    • the IBC is advised immediately of any accidents, injuries or illnesses associated with dealings, projects or permits involving use of regulated biological goods, and submit UniSafe reports where required.
    • the IBC is advised immediately of any unintentional releases, loss, theft or unauthorised access or use of regulated biological goods.
    • that the IBC’s representatives (Research Compliance Officers) and OGTR Inspectors are granted access to the containment facility for the purpose of undertaking audits, inspections and assisting with incident response.
    • all personnel are provided with adequate training in emergency procedures, including for spills, fires and explosions, before they commence working in a containment facility.
  • Principal investigator

    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 risk assessments for work with RG2 microbiological samples have been submitted to and accepted by the IBC.
    • ensure that an appropriate DAFF import permit is obtained prior to the ordering or importation of any biological goods.
    • ensure that all work with GMOs or GSTBC does not deviate from the terms of the approval, licence or permit.
    • 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 associated with regulated biologicals are appropriately trained in the procedures they are undertaking and the associated risk controls.
    • ensure that safe working procedures are understood by staff and students and are enforced.
    • enforce containment facility behavioural requirements for staff and students under your supervision.
    • 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 illnesses associated with dealings, projects or permits involving use of regulated biological goods, and submit UniSafe reports where required.
    • advise the IBC and Facility Manager immediately of any unintentional releases, loss, theft or unauthorised access or use of regulated biologicals.
    • maintain a register of all regulated biologicals stored or in use under each approved dealing, licence or permit.
    • advise the IBC of any changes to approved work, including changes to personnel and facilities, and to notify the IBC upon the completion of the project.
    • ensure applications are submitted to renew expiring dealings, permits or risk assessments 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 work being contained.
  • Head of School or Department

    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 regulated biologicals and containment facilities.
    • they are aware of all IBC approved projects being undertaken in their School or Department.
    • effective practices are in operation to comply with relevant legislation, guidelines and standards.
    • ensuring that the School/Department appropriately resources containment facilities to allow them to be maintained in accordance with guidelines and standards relevant to certification.
    • Principal Investigators and Facility Managers are supported to undertake appropriate training to enable them to execute their responsibilities.
    • information required by the IBC for the purposes of reporting to the OGTR, DAFF or ÐÓ°ÉÖ±²¥ is provided.
    • any breaches or acts of non-compliance by personnel are reported to the IBC.
    • that the IBC is advised immediately of any accidents, injuries or illnesses associated with dealings, projects or permits involving use of regulated biologicals and subsequently provide a report on the investigation of such incidents.
    • that the IBC is advised immediately of any unintentional releases, loss, theft or unauthorised access or use of regulated biologicals.
  • Executive Dean

    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 legislation, guidelines and standards relating to regulated biologicals and containment facilities.
  • Deputy Vice-Chancellor (Research)

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

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

    If you are working with GMOs and/or undertaking research (of any kind) in a 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 containment facility.

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

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

    If you are required to enter a containment 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 containment facility - wait for the Facility Manager.

  • Liability

    The OGTR, DAFF and SafeWork SA have extensive powers to allow monitoring and enforcement of legislation under their purview.

    The Gene Technology Act establishes offences for unauthorised dealings with a GMO. If a researcher knowingly undertakes GMO work for which a licence is required and the researcher does not have one, the person concerned is not covered by ÐÓ°ÉÖ±²¥ indemnity. Further information is available in the Act.

    The Biosecurity Act 2015 establishes infringement processes and civil penalties for the unauthorised import of biological goods, including but not limited to prohibited biological goods, and for non-compliances relating to GSTBC and Approved Arrangements. Further information is available in the Act.

    The South ÐÓ°ÉÖ±²¥n Work Health and Safety Act establishes penalties and criminal offences for work that endangers or exposes a person to risk of death, serious injury or illness. Further information is available at .

    The penalties for unauthorised dealings with GMOs, unauthorised import of biological goods, non-compliant handling of GSTBC or for working in a way that exposes a person to risk of serious injury or illness can include significant fines or imprisonment.

    The ÐÓ°ÉÖ±²¥ 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. Penalties applied under the Biosecurity Act may also prohibit future imports or operation of Approved Arrangements and can also affect our OGTR ‘Accredited Organisation’ status. This would all have a huge detrimental effect on the ÐÓ°ÉÖ±²¥â€™s ability to conduct research.

    For all work with regulated biologicals, personnel are within their rights to ask for a copy of the approval, licence, risk assessment or permit and should they be required to work in a way which could breach the approval 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.

  • How the ÐÓ°ÉÖ±²¥ supports compliance

    The ÐÓ°ÉÖ±²¥'s Institutional Biosafety Committee assists the ÐÓ°ÉÖ±²¥ of Adelaide to comply with legislation and standards relating to gene technology, GMOs and work with microorganisms, and does this by:

    • providing advice to staff and students about relevant legislation, standards 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.
    • assessment and review of risk assessments for work involving risk group 2 (or higher) microorganisms and samples containing these.
    • ensuring that appropriate registers are maintained of all gene technology dealings, genetically modified organisms, work with risk group 2 (or higher) microorganisms, personnel who have undertaken training, incidents.
    • maintaining a list of containment 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 undertaking research and teaching with gene technology, GMOs and risk group 2 (or higher) microorganisms.

    In addition, the Research Compliance Officers provide support for regulated activities under the Biosecurity Act 2015, including:

    • providing advice to staff and students about the Act and associated regulations and guidelines.
    • providing advice to staff and students on the requirement for import permits, appropriate permit categories, and technical support in applications for permits made to DAFF.
    • maintaining a list of Approved Arrangements, carrying out annual inspections and supporting Facility Managers during DAFF audits.
    • preparing submissions or correspondence with DAFF as required.
    • liaising with the DAFF regarding every aspect of Approved Arrangements.
    • providing training for staff and students in the requirements for importation of biological goods, and requirements relating to Approved Arrangements.

Biological compliance team - Research Services

Gene Technology / Institutional Biosafety Committee enquiries: ibc@adelaide.edu.au
Biosecurity enquiries : importcompliance@adelaide.edu.au

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