> IBC & Accredited Orgs
Frequently asked questions
How do I know if the research I am doing requires a licence or other approval?
The level of regulation depends on the classification of your research in the Gene Technology Regulations 2001 (Schedules 1A - 3).
It is advisable to consult your Institutional Biosafety Committee (IBC) to determine whether or not the proposed work requires a licence or other approval. Some guidance is provided on the IBC and Accredited Organisations Information Page
When can I start my work?
If your work requires a licence, you must not start work until the licence has been issued by the Gene Technology Regulator.
If your work can be classified as a Notifiable Low Risk Dealing (an NLRD), your proposed work must be assessed by an IBC. You can start work when the IBC notifies you (and the nominated project supervisor), in writing, that they have assessed the proposed dealing as an NLRD and that they consider the personnel involved to have appropriate training and experience.
If your work is exempt, you can start at any time. (Note that your organisation may have requirements relating to the conduct of exempt dealings beyond those under the Gene Technology Act 2000
. It is advisable to consult your IBC).Top of page
What do I do if I want to alter the dealings I am undertaking under an existing approval (e.g. licence, certification)?
You may apply for a variation to an existing licence or certification relating to work with GMOs by writing to the OGTR
, setting out details of the authorisation (i.e. number and title), the nature of the variation being requested and the reasons why it should be granted, including how you propose to manage any risks arising from the variation. The requested variation may not commence unless approved in writing by the Regulator. A variation will only be approved if the Regulator is satisfied that the risks can be managed and that the proposed variation is in accordance with requirements under the legislation. For further information, including guidance on the types of changes that are likely to be accepted as variation, see the Policy on the Variation of GMO Licences
or the Policy on Requests for Variation, Transfer, Surrender or Suspension of Certification
If two organisations are planning to collaborate on a licensed dealing, which organisation should apply for the licence?
As long as the organisations are accredited and the facilities are certified, either organisation can be the applicant organisation. The licence will be issued to the applicant organisation, which will be responsible for compliance with all licence conditions. Similarly, the holder of certification is responsible for ensuring compliance with certification conditions.
What are the requirements for transport and supply of GMOs to other organisations?
It is the responsibility of all people and organisations handling GMOs to ensure that the correct approvals (e.g. licence, NLRD) are in place to possess, use and supply GMOs. When GMOs are being sent between organisations it is each organisation’s responsibility to ensure it has the correct approvals (e.g. the receiving organisation is responsible for ensuring it has approvals in place before requesting the supply of GMOs).
DIR and DNIR Licences
If you have a licence authorising dealings with GMOs, you must follow the conditions on the licence as to whether you may supply the GMOs to other parties and how the GMOs must be transported. If your circumstances have changed and you now wish to supply GMOs to other parties and your licence does not permit this, you must apply for a variation of your licence to enable this (see above
). You must not send the GMOs until the licence has been varied.
The GMOs must be transported in accordance with the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs
. It is recommended that the organisation keep a record of the supply and receipt of GMOs, including date and destination or source and advise any recipients that they require authorisation under the Gene Technology Act 2000
to possess the GMOs (i.e. a licence or NLRD).
The only legislative requirements for exempt dealings is that they must not involve intentional release into the environment.Top of page
Are exempt dealings exempt from regulation?
Exempt dealings are a category of dealing that includes dealings with certain host/vector/gene combinations (see Schedule 2 of the Gene Technology Regulations 2001
for details of the classification of exempt dealings). The only legislative requirements for exempt dealings is that they must not involve intentional release into the environment.
What are the requirements for backflow prevention in certified facility?
'Backflow' is any unwanted flow of used or non-potable water, or other substances, into the drinking (potable) water distribution system.
The Gene Technology Regulator has made a policy decision that requires that:
- Backflow prevention must be installed for PC3 and PC4 facilities.
- A risk assessment of the GMOs involved in dealings must be undertaken for all PC2 facilities to determine whether backflow prevention is necessary. If the risk assessment indicates backflow prevention is necessary, appropriate prevention measure must be taken.
- The backflow prevention risk assessment must be available on request to authorised OGTR staff and must be updated when using new GMOs in the facility.
The requirements for backflow prevention will be progressively implemented as and when respective certification guidelines are reviewed and re-issued. For more information on the risk assessment requirements, refer to OGTR Policy on Backflow Prevention in Certified Facilities
How do I import and export GMOs?
If you are importing a GMO, you need authorisation under both the Quarantine Act 1908, administered by the DAFF Biosecurity
the Gene Technology Act
2000, administered by the Gene Technology Regulator. Authorisations under the Act depend upon the nature of the GMO and on the proposed dealings, and may be in the form of a licence, a NLRD or listing as an exempt dealing. When seeking a quarantine import permit from DAFF Biosecurity
for a GMO, importers will be required to provide details of their authorisation under the Gene Technology Act 2000
(e.g. a licence number or NLRD number) on the import permit application form
. Both DAFF Biosercurity
and OGTR approval must be obtained prior to the importation of the GMOs into Australia.
While the export of GMOs itself is not a dealing and therefore does not require authorisation under the Gene Technology Act 2000, authorisation is required for the transport occurring inside Australian borders. You also need to ensure that you have the relevant approvals from other Australian regulators (e.g. Department of Defence for organisms on the Defence and Strategic Goods List
) and from the receiving country or countries. You should also notify the OGTR of your intention to export GMOs to ensure it does not impact on your existing licence(s).
How can I contact OGTR?
Free call: 1800 181 030
Fax: 02 6271 4202
Mail: Office of the Gene Technology Regulator (MDP 54)
GPO Box 9848
Canberra ACT 2601
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