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 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 - 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 NLRDsThe 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 this document in EXCEL format.
Record of proposed NLRDs - Version 9 - Excel 25 KB
Record of proposed NLRDs - Version 9 - PDF 68 KB
Record of proposed NLRDs - Version 9 - DOCX 17 KB
Instructions about the content of fields are included as notes in the spreadsheet, when a field is selected.
The notes can also be found below:
Instructions on NLRD Reporting Requirements Version 9 - PDF 117 KB
Instructions on NLRD Reporting Requirements Version 9 - DOCX 35 KB
Forms should be submitted by email: firstname.lastname@example.org
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).
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) 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.
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 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).
See – Webpage outlining the IBC’s roles and responsibility for this guidance document
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 (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.