Notifiable Low Risk Dealings (NLRDs) are activities with GMOs undertaken in containment (i.e. not released into the environment) that have been assessed as posing low risk to the health and safety of people and the environment provided certain risk management conditions are met.
The types of GMOs and activities classified as NLRDs are specified in the Gene Technology Regulations 2001 (the Regulations).
NLRDs must be:
- assessed by an Institutional Biosafety Committee as being an NLRD
- conducted by people with appropriate training and/or experience
- conducted within a facility certified to either Physical Containment level 1 (PC1), PC2 or PC3 (as appropriate), or another facility specifically approved by the Regulator for a particular NLRD, and in accordance with any conditions imposed on the facility
- transported, stored and disposed of according to the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs.
The person/organisation must undertake the dealings in accordance with the requirements of the Regulations, notify the Regulator about NLRDs assessed during the financial year as a part of their organisation's annual report, and give a copy of the IBC RoA to the Regulator upon request. Forms for recording NLRD assessments and notifying the Regulator are available below or from the Forms page.
NLRDs notified to the Regulator are assigned a reference number (NLRD number) by the OGTR. The List of NLRDs notified to the Gene Technology Regulator on the OGTR website, which forms part of the GMO record, is updated annually, once all organisation annual reports are received. (Note that this may not occur until early in the calendar year following the submissions, as it takes time to collate all NLRDs from the previous financial year). The assigned NLRD numbers are also then communicated to the notifying organisation.
NLRD categories specified in Schedule 3 of the Regulations:
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Guidance on making a Record of Assessment for an NLRD and on responsibilities for those undertaking NLRDs:
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Model Form - Records of Assessment Notifiable Low Risk Dealings (NLRDs)
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Operational Policy on Requests for undertaking Notifiable Low Risk Dealings (NLRDs) in alternate facilities – posted 1 August 2013
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Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors (HTML)
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