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Licensed dealings with GMOsSchedule 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 environmentChanges to DNIRs | DNIR Application forms | Application Guidelines DNIRs which became NLRDsA 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 licenceComplete 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 applicationIt 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 table to assist those investigators working with defective viral vectors to determine which category of dealing their work falls into. 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 environmentChanges to DIR licence applications | Limited and controlled releases | Other releases | State Regulation of GM Crops | DIR Application process and forms Changes to DIR licence applicationsThe current Regulations have streamlined 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' releasesThis 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 'limited and controlled' DIR category has a:
Other (general) releasesAny 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:
This DIR category has:
State Regulation of GM CropsLegislation 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 licenceThe 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:
Conditions and responsibilitiesSpecific licence conditions are stipulated for each licensed dealing. In general however, investigators must ensure that:
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© 2005 The University of Adelaide Last Modified 22/11/2009 RECU CRICOS Provider Number 00123M |
