Who needs accreditation
The Gene Technology Regulator requires organisations undertaking certain dealings with genetically modified organisms (GMOs) to be accredited.
The Regulator also strongly encourages all organisations conducting dealings with GMOs to obtain accreditation.
This helps manage any risks of dealing with GMOs.
What accreditation means
Accreditation enables the Regulator to assess whether an organisation has the appropriate governance arrangements, resources and internal processes in place to effectively oversee work with GMOs.
Accredited organisations must comply with the conditions of accreditation.
Accreditation does not allow an organisation to conduct dealings with GMOs. The organisation must still obtain the correct approval or assessment before commencing.
Before an organisation can be accredited it must have access to an appropriately constituted Institutional Biosafety Committee.
Institutional Biosafety Committees
Institutional Biosafety Committees (IBCs) play an integral role in assisting compliance with Australia’s national gene technology regulatory scheme laws.
IBCs evaluate low-risk contained dealings that do not require case-by-case consideration by the Regulator.
They also provide a quality assurance mechanism by reviewing the information applicants submit to the Regulator.
IBCs are not responsible for the conduct of organisations that they assist. They help with identifying and managing risks with GMOs without attracting liability for damages.
Accredited organisations may have multiple IBCs specialising in different fields of expertise. Organisations may also seek advice from IBCs established by another organisation.
- Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives
- Requirements under the Gene Technology Act 2000 for clinical trials in humans involving GMOs – Guidance for clinical trial sponsors
Apply for accreditation
The application must address a number of technical and procedural matters. The Regulator considers the level of compliance with the technical and procedural requirements outlined in the guidelines in determining whether to accredit an organisation.
The Regulator must decide whether to approve accreditation within 90 working days of receiving the application.
This does not include weekends, ACT public holidays, and time spent waiting for applicants to respond to requests for additional information.
Protecting confidential commercial information
Applicants can request that information in the accreditation application is declared confidential commercial information (CCI). Applicants must include any CCI request with the application for accreditation