Apply to develop high-risk GMOs

A high-risk GMO is defined as any organism that does not meet the requirements of low-risk genetic modification as defined in the HSNO (Low Risk Genetic Modification) Regulations, 2003.

Typical higher-risk GMO applications 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 RG3 hosts

There are two pathways for obtaining approval to develop high-risk GMOs. The first pathway involves applying to use one of the existing high-risk HSNO approvals held by the University. If your work does not fit within these approvals, the second pathway is to apply for a new higher-risk HSNO approval from the EPA.

The University has a number of HSNO approvals for the development of specific higher-risk GMOs. Researchers who wish to use these HSNO approvals must first apply to the UABSC for approval to use an existing approval.

Existing HSNO approvals for the development of specific high-risk GMOs:

• ERMA200732 – covers packaging and use of replication-defective viral vectors in specified species of cell lines and rodent tissue. This approval covers a wide range of inserts, but genes from persons of Māori descent are excluded. This approval also covers the genetic modification of some viruses. The controls on this approval are prescriptive.
• APP202619 – covers the production of specified cell lines with Sendai viruses with Yamanaka factors (which includes the oncogene c-myc). The controls on this approval are outcome-based.
• APP203324 – covers packaging and use of replication-defective retroviral vectors with oncogenes in specified species of cell lines. It also covers the immortalisation of cell lines using replication-defective retroviral vectors. Genes from persons of Māori descent are not excluded. The controls on this approval are outcome-based.

There are also HSNO approvals for specific species and purposes. These approvals include the use and production of AAV and retroviral vectors for neurological research, the importation of Hepatitis B virus-expressing cell lines and the genetic modification of Mycobacterium tuberculosis. Further details regarding these specific approvals can be obtained from the biosafety officer.

Applicants wishing to use an existing high-risk HSNO approval must:

• Contact the biological safety officer to discuss the proposed project and the relevant higher-risk HSNO approval.
• Create a new UoA biological safety application – “Application to use an existing HSNO approval” using Infonetica Ethics RM, following the steps in the Infonetica Ethics RM – Creating an application guide.
• Submit the application following the steps in the Infonetica Ethics RM – Submitting an Application – no sign-off (Biological Safety Committee applications only) guide.
• Only the principal investigator can submit the application, as they will be required to agree to the terms and conditions during submission.

Other PIs with similar projects and GMOs can duplicate an approval and amend project details as applicable for their approvals.

The application must be submitted at least 10 working days before the next UABSC scheduled meeting.

If the development of a GMO is not covered by an existing HSNO approval, an application will have to be made to the EPA to obtain a new HSNO approval.

The Deputy Vice-Chancellor Research and Innovation requires that the University, UABSC, and the operators of containment facilities are aware of all applications made to the EPA.

Applications to the EPA to develop new high-risk GMOs must therefore be submitted to the UABSC in the first instance. While the UABSC is unable to provide a formal assessment of the application, the committee and the biological safety officer will provide advice and support for applicants.

Applicants wishing to apply for a new high-risk HSNO approval from the EPA must:

• Contact the biological safety officer for advice on completing the application.
• Create a new UoA biological safety application – “Applications to the EPA (Develop a new HSNO approval)” using Infonetica Ethics RM.
• Follow the steps in the Infonetica Ethics RM – Creating an application guide. This will allow you to submit a copy of the HSNO application for inclusion in the agenda of an upcoming UABSC meeting. The application must be submitted at least 10 working days before the next UABSC scheduled meeting.

The UABSC will provide feedback to the applicant, who will work with the biosafety officer towards the final draft.

Upon satisfaction of the UABSC, the application will be submitted by the biological safety administrator to the EPA on behalf of the applicant. A copy of the approval will be held by the UABSC administration when received.

Advise the UABSC of any further amendments or variations and subsequent approvals.

Head of Research Ethics
Email: Dr Dana Wensley

Hazards and Containment Manager and Biosafety Officer
Email: Dr Francesca Casu