Where practical, documents and forms supplied on this page are accessible in all formats. Forms can be submitted to the OGTR via email.
NLRD categories under the Gene Technology Regulations 2001 (the Regulations)Schedule 3 of the Regulations describes the types of dealings with GMOs that are classified as NLRDs. Part 1 of Schedule 3 lists NLRDs suitable for physical containment level 1. Part 2 of Schedule 3 lists the types of dealings that are classified as NLRDs suitable for physical containment levels 2 and 3. Part 3 of Schedule 3 lists dealings that are not NLRDs, and which require a licence from the Gene Technology Regulator.
As of 8 October 2019, the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 amend the Commonwealth Gene Technology Regulations 2001 (the Regulations). These changes will be adopted in the gene technology legislation of States and Territories at different times, and organisations operating under those laws (e.g. state agencies of those jurisdictions) must continue to follow the earlier legislation until this has occurred. For further information on the amendments, see the 2019 Amendments to the Regulations web page.
The following links contain an excerpt of Schedule 3 of the Regulations incorporating the above amendments:
Types of Dealings with GMOs classified as Notifiable Low Risk Dealings (NLRDs) – October 2019 (PDF 290 KB)
Types of Dealings with GMOs classified as Notifiable Low Risk Dealings (NLRDs) – October 2019 (DOCX 96 KB)
The following links contain an excerpt of Schedule 3 of the Regulations prior to the above amendments:
Types of Dealings with GMOs classified as Notifiable Low Risk Dealings (NLRDs) – September 2011 (PDF 227 KB)
Types of Dealings with GMOs classified as Notifiable Low Risk Dealings (NLRDs) – September 2011 (DOCX 92 KB)
These parts also refer to the host/vector systems described in Part 2 of Schedule 2 (Host/vector systems for exempt dealings). This list can be found in “What dealings with GMOs are classified as exempt dealings”
Record of AssessmentInstitutional Biosafety Committees (IBCs) must prepare a Record of Assessment (RoA) for each proposed NLRD they assess. It is recommended that IBCs use the model form provided by the OGTR to prepare their RoA to ensure all required information is present. It is strongly encouraged that the guidance document provided below be consulted when preparing an NLRD proposal or making a RoA.
Model Form - Records of Assessment (PDF 186 KB)
Model Form - Records of Assessment (DOCX 54 KB)
Guidance on making Record of Assessment (PDF 261 KB)
Guidance on making Record of Assessment (DOCX 168 KB)
The following links contain information on the correct classification of kinds of NLRDs to be included in the RoA for reporting online:
Classification of Notifiable Low Risk Dealings (NLRDs) – NLRD reporting form requirements – October 2019 (PDF 160 KB)
Classification of Notifiable Low Risk Dealings (NLRDs) – NLRD reporting form requirements – October 2019 (DOCX 17 KB)
Notification of NLRDsThe form below is required for reporting NLRDs assessed by IBC(s) during the financial year under Regulation 13C of the Gene Technology Regulations 2001. NLRDs are required to be notified to the Gene Technology Regulator.
Intermittent Reporting of NLRDsDue to the 2019 amendments to the Regulations, a notification of an NLRD assessed after 1 July 2020 can be provided to the Regulator using the Notifiable Low Risk Dealing (NLRD) Reporting form, in the following ways:
- · at any point in time from the date of assessment until the 30th September of the following financial year (e.g. on the day of assessment, monthly, quarterly etc.);
· individually or in bulk in the one reporting form.
Note: These provisions do not prevent accredited organisations from reporting NLRDs in the same manner as previous financial year's reporting i.e. alongside or just prior to submitting the accredited organisation's annual report.
NLRDs reported to the Regulator are published on the OGTR website as part of the Record of GMO Dealings. The list of NLRDs is updated quarterly.
For further information on how to report your NLRDs online, please see the Online forms help page.
The NLRD import template provided below is a tool for organisations to record the necessary details and then import the details into the online reporting form for submission. This excel spreadsheet is not to be used to submit NLRDs via email.
Excel version of NLRD import template (Excel 18 KB)
Notifiable Low Risk Dealings (NLRDs) Reporting Form (PDF 136 KB)
Notifiable Low Risk Dealings (NLRDs) Reporting Form (DOCX 21 KB)
Instructions about the content of fields are included on the introductory worksheets and as data entry notes in the spreadsheet, when a field is selected.
Operational Policy – Requests for undertaking NLRDs in alternate facilitiesThe purpose of this document is to inform researchers and organisations wishing to undertake NLRDs about the Regulator’s operational policy for considering requests to conduct NLRDs in alternate facilities, pursuant to regulation 13(2)(c). This document can be found on the Operational Polices page of the OGTR website.
Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectorsThis guidance document has been prepared to assist IBCs in assessing NLRD proposals involving dealings with retroviral vectors able to transduce human cells, particularly in assessing whether: persons have the appropriate training and experience to undertake the dealings; and the facilities are appropriate for the dealings. This document can be found on the Viral Vectors page of the OGTR website.
Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drivesThis document provides guidance for IBCs and researchers on the regulatory requirements for organisms containing engineered ‘gene drives’, including the physical containment (PC) level of facilities for notifiable low risk dealings (NLRDs). This document can be found on the Institutional Biosafety Committee page of the OGTR website.
Other general advice for regulated stakeholdersOther general advice is provided to regulated stakeholders from time to time in relation to their roles and responsibilities. The following advice is currently available on the OGTR website.
General advice from the Regulator on coverage of new technologies
For more information see the What are Notifiable Low Risk Dealings? page and the Frequently asked Questions - Accreditation, Institutional Biosafety Committees (IBCs) & Notifiable Low Risk Dealings (NLRDs) page on the website.