Austin IBC - Types of Approvals, Guides and Application Forms

A genetically modified organism (GMO) is one into which DNA from another species has been introduced, eg by infection, transformation or transfection. The Act describes four classes of experiments involving GMOs, referred to in the Act as dealings, which cover varying levels of associated risk.

• To categorise your dealing, check the list of approved host/vector systems [pdf 76kb], approved tissue culture vectors [pdf 64 kb] and viral vector guide [pdf 96kb].
• Recent changes to the Act have changed the classification of some dealings, including some that were formerly exempt. Download the summary of changes [pdf 124 kb] and the details of the new PC1 NLRD classification [pdf 156kb].

Non-GMOs

• Check the list of organisms that are not genetically modified organisms [pdf 64kb] as defined in the Gene Technology Regulations.
• If your work involves these organisms, then you do not need approval from the IBC and/or OGTR.

1. Exempt dealings

• considered to be of minimal risk, and require only approval by the IBC under the conditions of the Act.
• Download the guide to exempt activity [pdf 104kb]
• Download the Exempt dealing application form [doc 120kb]

2. Notifiable low risk dealings (NLRDs)

• cover dealings where a level of risk is inherent, but can be easily reduced or managed.
• are approved by the IBC, and reported to the OGTR via the annual report.
• must be performed in OGTR-certified containment facilities.
• Work on NLRDs can begin only once IBC approval has occurred.
• Download the guide to NLRDs [pdf 152kb]
• Download the NLRD PC1 application form [doc 84kb] or NLRD PC2 application form [doc 240kb]
  

3. Dealings not involving intentional release of the GMO into the environment (contained dealings or DNIRs)

• cover the next level of risk.
• are approved by the IBC, and the OGTR must then issue a licence to carry out the dealing before work can begin.
• must be performed in OGTR certified PC2 containment facilities.
• This process can take up to 3 months, so researchers are advised begin the licence application process as soon as possible to ensure that work can commence, and that all regulatory requirements are met.
• Download the guide to applying for a licence [not currently available, contact IBC Secretary]
• Download the DNIR application form [doc 332kb]
  

4. Dealings involving the intentional release of the GMO into the environment (DIRs)

• are the final category of work covered by the Act.
• If you believe you require a DIR licence, please contact the IBC Secretary.

Variation to an approved dealing

• If you wish to vary an approved dealing please download the application form [doc 36kb]