About Gene Technology Compliance
All University personnel who propose to deal with GMOs must obtain the appropriate approvals for their GMO work from the University of Adelaide Institutional Biosafety Committee (IBC) and where necessary the Office of the Gene Technology Regulator (OGTR) prior to commencing the work.
All non-university personnel intending to work with GMOs in University premises must also obtain the appropriate approvals from the University IBC.
Certain dealings with GMOs must be conducted within physical containment facilities that are certified by the OGTR. The purpose of certification is to ensure that the containment facility protects persons outside the facility from exposure to GMOs and prevents release of GMOs into the environment. Conditions of certification require certain procedures to be followed to ensure the safety of people and the containment of GMOs.
Application for approval of GMO dealings and for certification of facilities is made using the forms available on the University of Adelaide web site. Relevant links to OGTR web pages are also located in the Gene Technology Resources web site.
All personnel (including visitors) working with GMOs or in an OGTR certified facility (irrespective of whether they are working with GMOs) must be trained in the OGTR requirements.
All organisations that conduct genetic manipulation work are required to abide by the Gene Technology Act 2000, Gene Technology Regulations 2001 and the OGTR Guidelines and be Accredited by the Gene Technology Regulator. One aspect of compliance with accreditation is that an organisation will have access to a properly constituted Institutional Biosafety Committee (IBC).
The University of Adelaide IBC consists of ten members each with specialist knowledge in a particular relevant field. The IBC meets on a monthly basis.
How the University's IBC Supports Compliance
The University's Institutional Biosafety Committee assists the University of Adelaide 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 genetic manipulation 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 genetic manipulation dealings, genetically modified organisms, personnel working in certified facilities, personnel authorised to access certified facilities, 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 genetic manipulation research and teaching.
Organisations Accessing the University's IBC
Other accredited organisations access the University of Adelaide Institutional Biosafety Committee:
- SA Museum
- Australian Genome Research Facility Ltd (Adelaide Node)
- Australian Centre for Plant Functional Genomics
SA Institutional Biosafety Committee Network
The SA Institutional Biosafety Committee Network was established in 2004 with an aim to streamline and standardise the processes between accredited institutions dealing with GMOs in South Australia, to provide an information conduit to the OGTR and between the IBCs and to coordinate training/information sessions.
The IBCs of the SA IBC Network:
Australian Water Quality Centre Institute of Medical and Veterinary Science BresaGen Limited TGR Biosciences Pty Ltd Children, Youth & Women’s Health Service /Child Health Research Institute The Australian Wine Research Institute The Flinders University of South Australia / Flinders Medical Centre The University of Adelaide GroPep Limited The University of South Australia
With regard to working with GMOs or working in certified physical containment facilities, all personnel should be familiar with their responsibilities as listed below.
Each person working with GMOs or working in certified physical containment facilities has a responsibility to:
- understand and comply with the relevant codes of behaviour for working with GMOs and within a physical containment facility
- follow safe work procedures and practices
- undertake any required training - including 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
- be familiar with the area and institutional safety policy, and know the emergency procedures for spills, fire and accidents and any particular emergency procedures particular to their work
- be familiar with the particular standard operating procedures relevant to their work and the equipment that they utilise
- be familiar with the School/Department's standard operating procedures and relevant Occupational Health and Safety requirements
- advise their supervisor and the Facility Manager immediately of any accidents, injuries, illnesses or unintentional releases of GMOs
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
- only authorised personnel have access to the certified facility
- appropriate induction is provided for all personnel before they commence working in a certified facility and that ongoing training and supervision are provided
- effective Standard Operational Procedures are prepared which meet the facility's particular situation as well as the requirements of the OGTR
- all personnel are provided with adequate training in emergency procedures for spills, fires and explosions and for any particular hazards associated with their GMO work before they commence working in a certified facility
- all unauthorised personnel (eg. maintenance contractors) have had an adequate safety induction prior to the commencement of work or entry to a certified facility
- all personnel are familiar with the Facility Manual(s) (eg. standard operating procedures/safety and emergency procedures/equipment operation/maintenance procedures) for the certified facility
- safe work procedures and practices are followed by all personnel and that equipment is used and maintained in accordance to the manufacturer’s recommendations
- hazard control measures are implemented in consultation with management, staff and students
- adequate personal protective equipment is supplied
- preventative measures are instigated to minimise potential risks in the facility
- storage, transport and disposal of GMOs is in accordance with the IBC and OGTR requirements
- a register is maintained of all persons working in the certified facility and of personnel authorised to access the certified facility
- a register is maintained of all dealings undertaken within the certified facility
- a register is maintained of all GMOs within the certified facility
- a register is maintained of all training provided to staff and students and other personnel
- report to the IBC any information asked of them by the IBC (or their Head of School/Department on behalf of the IBC) for the purposes of reporting to the OGTR
- the IBC is advised immediately of any accidents, injuries or unintentional releases of GMOs which occur within certified facilities and subsequently provide a report on the investigation of such incidents
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
- implement hazard control measures in consultation with management and personnel and provide adequate training for all staff and students
- ensure that all staff and students undertaking work in relation to the GMO dealing are appropriately trained (eg. this includes staff in 'common access' roles and areas such as animal carers, tissue culture staff, etc)
- maintain a register of all GMOs in their work
- ensure that the storage, transport and disposal of GMOs is in accordance with the IBC and OGTR requirements
- ensure that facilities are maintained in accordance with relevant guidelines and identify and report hazards immediately
- be familiar with the School/Department's standard operating procedures and relevant Occupational Health and Safety requirements
- report to the IBC any information asked of them by the IBC (or their Head of School/Department on behalf of the IBC) for the purposes of reporting to the University or OGTR
- advise the IBC of any changes to the dealing and to notify the IBC upon the completion of the dealing
- advise the facility manager and the IBC immediately of any accidents, injuries or unintentional releases of GMOs or unexplained illnesses or absences and subsequently provide a report on the investigation of such incidents
Head of School or Department
The Head of School or Department has a responsibility to ensure:
- they are aware of all GMO work being undertaken in their School or Department
- all personnel undertaking GMO work obtain appropriate approvals
- that all approved GMO work does not deviate from the terms of the original approval
- effective practices are in operation to comply with the GT Act and Regulations
- principal investigators and facility managers are adequately and appropriately trained to enable them to execute their responsibilities
- effective induction and awareness programs are in place to ensure all personnel are well informed of their responsibilities
- safe working procedures are understood by staff and students and are enforced
- appropriate registers and records are maintained
- facilities are maintained in accordance with relevant guidelines and that hazards reported are addressed appropriately
- 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 IBC Secretary
- that the IBC is advised immediately of any accidents or unintentional releases of GMOs or unexplained illnesses or absences and subsequently provide a report on the investigation of such incidents
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
Deputy Vice-Chancellor (Research)
The Deputy Vice-Chancellor (Research) on behalf of the Vice-Chancellor is responsible for:
- authorising applications for 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
- 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 should read 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 work in a certified facility you should:
- report to the Facility Manager prior to entering the facility
- comply with any instructions or training provided by the Facility Manager
- follow any signage within the facility
In the event that 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. The legislation provides that a person must not deal with a thing they know to be a GMO without a licence authorising that dealing, unless:
- the dealing is a notifiable low risk dealing;
- the dealing has been specifically exempted from the application of the legislation under the regulations; or
- the dealing has been placed on the GMO Register.
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 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 or the GT Act, they should decline, discuss the matter with the principal investigator and/or report the matter immediately to the Head of School or Department.
The legislation describes two levels of offences – one that requires the establishment of knowledge or recklessness and one that does not (a strict liability offence). This enables the prosecution to pursue lower penalties for technical breaches of the legislation (without the necessity to prove knowledge or recklessness) and higher penalties for more serious breaches of the legislation where the Criminal Code requires that knowledge or recklessness be established.
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.
|Dr Amanda Highet
Research Compliance Officer (Gene Technology)
Secretary, Institutional Biosafety Committee (IBC)
|Gene Technology Compliance & IBC enquiries:
Tel: +61 8 8313 6105
|Office of Research Ethics, Compliance & Integrity
Research Services, The University of Adelaide
Level 4, Rundle Mall Plaza, 50 Rundle Mall
ADELAIDE SA 5000