Approval of Work Involving the Development of Organisms with Low-Risk and High-Risk Genetic Modifications Policy

This document applies to all staff members and students of the University.

To ensure that the University of Auckland Biological Safety Committee (UABSC) has oversight of all applications and approvals for the importation or development of Genetically Modified Organisms and to ensure compliance with statutory obligations under Hazardous Substances and New Organisms (HSNO) Act 1996.

Note - Under the HSNO Act (1996), all staff members of the University have a statutory obligation to obtain prior HSNO approval before commencing any development or importation of genetically modified organisms (GMOs).

Background

To facilitate Low-Risk Genetic Modification within the Universities containment facilities, the UABSC has obtained a University Wide Low-Risk HSNO Approval (APP202708).

1. Principal investigators seeking to develop low-risk genetically modified organisms covered by the University wide approval must apply for approved user status.
2. Approved user status will be granted for a period of up to three years at which point principal investigators must apply for renewal.
3. Principal investigators must inform the UABSC of any changes to their project in the form of an amendment request.
4. Applications, amendments and renewals of approved user status are to be submitted to the UABSC.
5. If the proposed development of genetically modified organisms are outside the scope of the University Wide Low-Risk HSNO approval then the applicant will be directed to obtain approval by either applying to use another existing HSNO approval or by application to the Environmental Protection Authority (EPA). Note - Please refer to the High-Risk GMO Policy.
6. In addition to the requirement for HSNO approval, all GMOs must be imported into, or developed and used within, the confines of an MPI approved containment facility and comply with any additional controls imposed as a condition of the HSNO approval or approved user status and the Biological Risk Management and Containment standard.
7. Research projects that involve GMOs must include the HSNO approval number and/or approved user status application reference, on the research application coversheet, and will not be activated until the UABSC has assessed and approved the development or importation of the GMO.

1. Principal investigators wishing to import or develop GMOs that are classified as Not Low-Risk (i.e. High-Risk Genetic Modification) or are not covered by the University Wide Low-Risk HSNO approval must have a relevant HSNO approval issued from the Environmental Protection Agency (EPA).
2. The University holds a number of HSNO approvals for the development of specific High-Risk GMOs. Principal investigators who wish to use these HSNO approvals must first apply to the UABSC for “Use of an Existing Approval”.
3. Applications for “Use of an Existing Approval” are to be submitted to the UABSC.
4. In the event that work does not fit within an existing HSNO approval then principal investigators will need to apply for a new HSNO approval from the EPA.
5. All HSNO applications made by principal investigators to be assessed by the EPA must be first sent to the UABSC for the purposes of notification and assessment.
6. HSNO applications approved by the EPA are not able to be used by the applicant unless approved to do so by applying to the UABSC for “Use of an Existing Approval”.
7. In addition to the requirement for HSNO approval, all GMOs must be imported into, or developed and used within, the confines of an MPI approved containment facility and comply with any additional controls imposed as a condition of the HSNO approval and the Biological Risk Management and Containment Standard.
8. Research projects that involve GMOs must include the HSNO approval number on the research application coversheet and will not be activated until the UABSC has assessed and approved the development or importation of the GMO.

The following definitions apply to this document:

Approved user is a principal investigator given permission to develop low-risk genetic modifications in containment under the University Wide HSNO approval and is responsible for ensuring compliance and safety.

Biological Risk Management and Containment Standard is a set of standard operating procedures and good practice guidelines used to manage the containment of genetically modified organisms (GMOs) and risk biologicals at the University of Auckland.

Containment facility is a place approved by MPI in accordance with section 39 of the Biosecurity Act, for holding organisms that should not become established in New Zealand.

EPA is the Environmental Protection Authority of NZ.

Genetically modified organisms as per Section 2 HSNO Act are: "Any organism in which any of the genes or other genetic material.

a) have been modified by in vitro techniques; or
b) are inherited or otherwise derived, through any number of replications, from any other genes or other genetic material which has been modified by in vitro techniques

High-Risk Genetic Modification see Not Low-Risk Genetic Modification

Low-Risk Genetic Modification is defined as Category A or Category B development in the HSNO (Low-Risk Genetic Modification) Regulations, 2003.

Category A experiments are the lowest risk category and are defined as:

• genetic modifications using cell lines and microorganisms that are unable to cause disease and in which the nucleic acid insert will not impart any hazardous properties to the construct.
• These experiments can be safely contained within laboratories meeting PC1 containment standards

Category B experiments are of moderate risk and include:

• Experiments with approved host/vector systems where the insert may be expressed as a hazardous protein.
• Experiments using microorganisms or cell lines as hosts which are unlikely to be a serious hazard to laboratory personnel, the community or the environment and in which the insert is well characterised.
• Developments involving whole animals or plants.
• Experiments safely contained under PC2 containment standards.

MPI is the Ministry for Primary Industries.

Not Low-Risk Genetic Modification is defined as all modifications that do not meet the requirements of Low-Risk Genetic Modification as defined in the HSNO (Low-Risk Genetic Modification) Regulations, 2003. Examples include:

• Genetic modification using viral vectors where the inserted DNA encodes proteins known to be involved in uncontrolled cell growth
• Genetic modification with genes encoding highly toxic proteins
• Genetic modification of pathogenic hosts that cause serious human, animal or plant disease.

Principal investigator is a staff member responsible for a specific research project. The principal investigator is responsible for assuring compliance with applicable University standards and procedures, and for the oversight of the research study and the informed consent process. Although the Principal Investigator may delegate tasks to members of their research team, they retain responsibility for the conduct of the study.

Staff member refers to an individual employed by the University on a full or part-time basis.

University means the University of Auckland and includes all subsidiaries.

University Wide Low-Risk HSNO Approval refers to the HSNO approval number APP202708.

• Hazardous Substances and New Organisms (HSNO) Act 1996
• HSNO (Low-Risk Genetic Modification) Regulations, 2003
• Health and Safety at Work Act 2015
• Approval of Higher-Risk Genetically Modified Organisms Policy
• University of Auckland Low-Risk HSNO Approval APP202708
• University of Auckland Low-Risk HSNO Approved user application form
• University of Auckland Low-Risk HSNO Approved user guidelines
• Biological Risk Management and Containment Standard

Owned by: Deputy Vice-Chancellor (Research & Innovation)
Content manager: Biological Safety Officer
Approved by: Vice-Chancellor
Date approved: July 2021
Date last reviewed or amended: August 2026
Next review date: August 2029