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.

Excerpt from Schedule 3 of the Gene Technology Regulations 2001 (the Regulations).
NLRD categories in Schedule 3 - HTML
NLRD categories in Schedule 3 - PDF 93 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 Assessment

Institutional 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 - DOCX 56 KB
Model Form - Records of Assessment - PDF 53 KB

Guidance on making Record of Assessment - DOCX 103 KB
Guidance on making Record of Assessment - PDF 504 KB

Notification of NLRDs

The following form is required for reporting NLRDs assessed by IBC(s) during the financial year under Regulation 13C of the Gene Technology Regulations 2001. This record is to be submitted to the OGTR in an annual report for the financial year in which the NLRD was assessed. For Accredited Organisations, the notification of NLRDs is part of the organisation’s annual report which is required to be submitted under the conditions of accreditation. The form and instructions for completing the form are provided below.

The
NLRDs reported to the Regulator are published on the OGTR website as part of the Record of GMO Dealings, and is updated annually.

OGTR prefers to receive the NLRD records via the online reporting form or in EXCEL format



For further information on how to report your NLRDs online, please see the Online forms help page.

Excel version of Record of proposed NLRD for 2017-2018 - Version 9 (Excel 25 KB)
Excel version of NLRD import template 2017-2018 (Excel 17 KB)

Excel version of NLRD import template 2018-2019 (Excel 18 KB)

The NLRD import template is a tool for organisations to record the necessary details and then import the details into the online reporting form for submission.

Accessible formats
PDF version of Record of proposed NLRD for 2017-2018 - Version 9 (PDF 68 KB)
DOCX version of Record of proposed NLRD for 2017-2018 - Version 9 (DOCX 17 KB)

PDF version of NLRD import template 2017-2018 (PDF 12 KB)
DOCX version of NLRD import template 2017-2018 (DOCX 19 KB)

PDF version of NLRD import template 2018-2019 (PDF 12 KB)
DOCX version of NLRD import template 2018-2019 (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.
The notes can also be found below:

PDF version of Instructions on NLRD Reporting Requirements for 2017-2018 - Version 9 (PDF 117 KB)
DOCX version of Instructions on NLRD Reporting Requirements for 2017-2018 - Version 9 (DOCX 35 KB)

PDF version of NLRD import template 2017-2018 – Explanatory Document (PDF 26 KB)
DOCX version of NLRD import template 2017-2018 – Explanatory Document (DOCX 32 KB)

PDF version of NLRD import template 2018-2019 – Explanatory Document (PDF 29 KB)
DOCX version of NLRD import template 2018-2019 – Explanatory Document (DOCX 37 KB)

Excel forms should be submitted by email: ogtr.applications@health.gov.au

Operational Policy – Requests for undertaking NLRDs in alternate facilities

The 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).

Operational Policy on Requests for undertaking NLRDs in alternate facilities – HTML
Operational Policy on Requests for undertaking NLRDs in alternate facilities – PDF 188 KB

Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors

This 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.

Guidance for IBCs assessing NLRDs involving retroviral - including lentiviral - vectors (HTML)
Guidance for IBCs assessing NLRDs involving retroviral - including lentiviral - vectors - PDF 114 KB

Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives

This 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).

See – Webpage outlining the IBC’s roles and responsibility for this guidance document

Other general advice for regulated stakeholders

Other 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 (HTML)

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.

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