Notifiable Low Risk Dealings (NLRDs) are described in the Gene Technology Regulations 2001 (the Regulations), and are dealings with GMOs 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.
NLRDs must be:
- conducted by persons with appropriate training and experience within a facility certified to either Physical Containment level 1 (PC1), PC2 or PC3;
- assessed by an Institutional Biosafety Committee established by Accredited Organisation; and
- transported, stored and disposed of in accordance with the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs
IBCs must prepare a record of assessment of each proposed NLRD. Copies of the IBC record of assessment must be provided to the person/organisation which requested the assessment for the NLRD. The person/organisation must be able to make a copy of the record of assessment available to the OGTR upon request, and must provide information to the OGTR as a part of each organisation's annual report. A model form for recording NLRDs is available below or from the Forms page.
Schedule 3, Parts 1 and 2 of the Regulations specifies the kinds of NLRDs suitable for PC1, PC2 and PC3.
NLRD categories as from 1 September 2011 - posted 1 September 2011
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Guidance for making Records of Assessment of NLRDs
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Model Form - Records of Assessment Notifiable Low Risk Dealings (NLRDs)
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List of NLRDs as notified to the Gene Technology Regulator
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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