Licensed dealings with GMOs
Schedule 3 of the Regulations outlines the kinds of dealings that require a licence. Note that some dealings previously requiring a DNIR licence may now be classified as NLRD.
DNIR - Licensed dealings not involving the intentional release of a GMO into the environment
Changes to DNIRs | DNIR Application forms | Application Guidelines
DNIRs which became NLRDs
A DNIR licence for a dealing which now only requires an NLRD can be surrendered. You should make a request to the IBC to surrender the DNIR licence before the DNIR licence expires. However, if you wish, the licence can be retained, with all existing licence conditions being followed.
Application for DNIR licence
Complete the OGTR DNIR application form, an IBC Application Coversheet and the Statement of suitability: Project Supervisor and send them to the IBC Secretary. Please send the DNIR Application form in hard copy as well as electronic copy to the IBC Secretary. The assessment process will only proceed on receipt of all completed forms.
If relevant, also complete a declaration that specified information is confidential commercial information (CCI) by completing the OGTR form.
Some things to consider when completing an application
It is important to provide information that is as comprehensive as existing scientific knowledge permits, and supported by whatever data are available. When completing your application paperwork, refer also to the OGTR Risk Analysis Framework (Version 2.2 November 2007) which describes the principles of risk analysis used by the Regulator when determining whether a licence is to be issued.
The OGTR also requires that all storage of GMOs is authorised and that the GMOs are stored safely. When submitting a DNIR application, investigators should include any proposed storage period in their considerations of the 'expected completion date' in order to keep any potential stored GMOs authorised.
Investigators should also ensure that all proposed transport, including importation or exportation, of GMOs is included in the dealing as these aspects of a dealing also require approval.
The OGTR has issued a series of documents to assist those investigators working with defective viral vectors to determine which category of dealing their work falls into:
- Guidance flowchart for the classification of contained dealings with viral vectors
- Guidance tables on the changes to the classification of contained dealings with viral vectors resulting from the implementation of the Gene Technology Amendment Regulations 2011 (No. 1)
- Guidance tables for the classification of contained dealings with viral vectors
The IBC will assess the application, which may require the principal investigator providing additional information. The IBC will endeavour to process the application within four weeks. You will be advised in writing of the outcomes of the assessment. The University submits each licence dealing application including an IBC evaluation report to the OGTR upon endorsement by the IBC.
The OGTR will then undertake an extensive risk analysis. Further information may be required by the OGTR from the principal investigator during the review process. The statutory time period for the Regulator to make a decision on a DNIR application is 90 working days. There are however, a number of ways in which the 90 day period could be extended (eg. additional information/clarification required). From receipt of the application paperwork by the IBC it could thus take up to 4 or 5 months for a decision to be made and a licence issued. Investigators should allow for this when determining their proposed commencement date.
Licences are issued to the 'Applicant Organisation' (ie. the University, not the investigator) and specific conditions will apply for the work. A licence is generally issued for a maximum of 5 years. You must not commence licensed work until written confirmation has been received from the OGTR that you are authorised to do so. The licence will detail a number of conditions that must be complied with in relation to the dealings with the GMO.
DIR - Licensed dealings involving the intentional release of a GMO into the environment
DIR licence applications | Limited and controlled releases | Other releases | State Regulation of GM Crops | DIR Application process and forms
DIR licence applications
The Regulations streamline the DIR licence application process by separating the dealings involving release into two categories: 'limited and controlled' releases (such as field trials); and 'other' releases (such as commercial releases). The same DIR application form can be used for both categories and the Regulator will use information supplied by the applicant to determine the appropriate category, on a case-by-case basis.
'Limited and Controlled' releases
This category recognises that an application for release of a GMO for experimental purposes will usually be limited in terms of time, spatial scale and location. The consultation process for a 'limited and controlled' release is consequently simpler than for other (general) release applications.
In order for an application to fit into the 'limited and controlled' category it must satisfy all the requirements of section 50A of the Act, including:
- the principal purpose is to conduct experiments; and
- it is limited in scope, size, location and duration; and
- it has controls to prevent dissemination or persistence.
The 'limited and controlled' DIR category has a:
- statutory time limit for the decision on an application: 150 working days for a dealing which the Regulator considers does not pose significant risk; 170 working days for a dealing which the Regulator considers may pose significant risk;
- minimum 30-day consultation with the public and prescribed experts, agencies and authorities on the Risk Assessment and Risk Management Plan (RARMP).
Other (general) releases
Any DIR application that not does satisfy all the requirements of section 50A of the Act will fall into this category. This includes releases that are:
- commercial; or
- non-experimental such as seed increase; or
- unlimited in size, location and/or duration; or
- minimally controlled to prevent dissemination or persistence.
This DIR category has:
- statutory period of 255 working days for assessment;
- two minimum 30-day consultation rounds - (i) a consultation with prescribed stakeholders on the application and (ii) a second consultation round with the public, prescribed experts, agencies and authorities on the RARMP.
State Regulation of GM Crops
Legislation is in place to control the cultivation of genetically modified crops in South Australia.Genetically Modified Crops Management Regulations 2008 (made under the Genetically Modified Crops Management Act 2004) designate the whole of the state of South Australia as an area in which no genetically modified food crops may be cultivated.
However, the Act enables the Minister to confer an exemption for the limited scale cultivation of GM food crops, including experimental crops in areas where the cultivation of GM crops is otherwise prohibited. Exemption Notices issued by the Minister will have conditions attached to ensure that local production and supply chains are unaffected.
Application for DIR licence
The application process for this category of licence is involved and if you are planning an intentional release you should read carefully the information available on the OGTR web site and contact the IBC Secretary for further details.
Relevant OGTR information:
- OGTR DIR Application form
- Evaluation process and flow chart for intentional release licence applications
- The OGTR has issued a series of documents to assist those investigators working with defective viral vectors to determine which category of dealing their work falls into:
- Guidance flowchart for the classification of contained dealings with viral vectors
- Guidance tables on the changes to the classification of contained dealings with viral vectors resulting from the implementation of the Gene Technology Amendment Regulations 2011 (No. 1)
- Guidance tables for the classification of contained dealings with viral vectors
- OGTR Form for declaration that specified information is confidential commercial information (CCI)
- Risk Analysis Framework (Version 2.2 November 2007) which describes the principles of risk analysis used by the Regulator when determining whether a licence is to be issued
- Biology documents prepared by the OGTR - these documents are used to inform the Risk Assessment and Risk Management Plans that are prepared in response to applications for dealings involving intentional release
Conditions and responsibilities
Specific licence conditions are stipulated for each licensed dealing. In general however, investigators must ensure that:
- only the dealings and experiments listed in the licence are undertaken
- the dealings with GMOs are undertaken only in the facilities specified in the licence
- for DNIRs, work must not involve an intentional release of the GMO into the environment - any unintentional release of GMOs must be reported to the IBC immediately
- the dealings are properly supervised and a record of the details of the dealings retained
- the IBC is notified in writing of any changes to personnel working on the licensed dealings
- authorised personnel covered by the licence are informed of and understand their obligations and are appropriately trained
- required records are maintained
- stored GMOs are authorised
- approval is sought in writing for any proposed changes to the dealing
- the Institutional Biosafety Committee is notified immediately:
- if any of the project supervisor's contact details change
- of any additional information as to any risks to the health and safety of people or to the environment associated with dealings authorised by the licence
- of any contraventions of the licence, including the unintentional release of a GMO
- of any unintended effects of the dealings authorised by the licence
