Information for Completion of Application Forms

Part 3A: Project supervisor

Include the extent of experience in years including microbiological experience and handling of GMOs.

Indicate relevant training courses undertaken.

Part 3B, 3C & 4A-F: About the Dealing and Description of GMO

3B: Please identify the researchers who will work on the project. This list will not prevent you from adding additional researchers to the project. When NLRDs are approved by the IBC, you will be advised in the IBC acceptance letter that your dealing may be conducted by any person approved by the ANU providing you notify the IBC of personnel changes in your annual report. (Please note that this is not the case with licenced dealings (DNIRs). The Regulator must be aware of all of the people working on a DNIR at all times.)

4: Provide specific details of GMOs and explain the different aspects of the work and the various aims.  In this section include details of storage, transport, import or export of GMOs in accordance with the Guidelines for the Transport, Storage and Disposal of GMOs and the Guidelines for Certification of Facilities/Physical Containment Requirements.

4A: Parent organisms are those that are modified by DNA from another source. The simplest example would be E. coli as the parent organism being genetically modified by the introduction of foreign DNA.

Please note: Site directed mutagenesis does not involve the introduction of any foreign DNA and therefore does not create a GMO under the Gene Technology Regulations. Under Schedule 1, Item 1 of the Gene Technology Regulations 'A mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species)' is not a genetically modified organism.

Part 6: Risk assessment information & management

Please note that an answer "there is no risk" will not be accepted.

Risk Identification

The type and source of hazards must be identified and include what they threaten e.g. human health and/or the environment.

Risk has two dimensions, probability of an event and consequence (the impact of the event when it happens).

Risk Assessment evaluates the probability of harm to people and /or the environment due to exposure and the possible outcomes from exposure to each hazard. In other words, risks that have consequences and those that do not.  Hazards to the environment should cover direct and indirect effects on flora and fauna, habitat, biodiversity and soil, air and water.

Risk Management

Identify the various risk factors and provide an overall risk assessment and management plan to control or lessen the risk and mitigate any adverse events.

The following documents are available from the OGTR website to provide information relating to the risk management information required for Licenced Dealing applications.

• Risk Analysis Framework 2009
• Gene Technology Regulations 2001: Section 10: Risk Assessment – matters to be taken into account

6D: Please list the facilities you will use. On approval an NLRD will not be limited to these facilities. You will be advised in the IBC acceptance letter that your dealing may be conducted in any present or future certified facility (appropriate for the requirements of the dealing) that the ANU grants access to, providing that the IBC is notified of facility changes in your annual report. (Please note that licenced dealings (DNIRs) are different. The Regulator must approve changes to facilities with a formal variation to the DNIR.)

DNIR Applications:

For Licenced Dealings (DNIRs and DIRs) the names of all the people working on the project must be included in the application and the OGTR must be notified (through the Secretary) of any changes so that the Regulator is aware of all of the people working on the project, at all times.  If at a later date an amendment is required, email the Secretary indicating the identification number of the licence and the names to be changed.

Please note regarding compulsory training. For Licenced Dealings, personnel working on the proposed dealing must be informed of the Licence Conditions issued by the OGTR when the licence is granted. This must be documented in the facility manual for each facility involved in the Licenced Dealing.  Additional training specific to the Licenced Dealing may also be required and should also be documented.