Approval of Work Involving the Development of Organisms with 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).

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:

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 of the 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

HSNO means “Hazardous Substances and New Organisms”

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 in 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.

Include the following:

• Hazardous Substances and New Organisms (HSNO) Act 1996
• HSNO (Low Risk Genetic Modification) Regulations, 2003
• Health and Safety at Work Act 2015
• United States National Institute of Health “Guidelines for Research Involving Recombinant DNA Molecules”
• Approval of Work Involving the Development of Organisms with Low-Risk Genetic Modifications
• Approval of Work Involving the Development of Organisms with High-Risk Genetic Modifications
• HSNO 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: DVC (Research)
Content manager: Ethics and Integrity Manager
Approved by: Vice-Chancellor
Date approved: July 2021
Review date: July 2026