Information for Completion of Application Forms

Part 2: Project supervisor

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

Indicate relevant training courses undertaken.

Part 3 & 4: About the Dealing and Description of GMO

For NLRDs, identify the person, persons or class of persons proposing to undertake the GMO.

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 (link to contact details) of any changes so that are 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 of the University Recombinant DNA Monitoring Committee (link to email) indicating the identification number of the licence and the names to be changed is sufficient information.

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.

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 of GMOs and the Guidelines for Certification of Facilities/Physical Containment Requirements.

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 November 2007

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