Institutional Biological Safety Committees and Low-Risk Genetically Modified Organism Decision Making

The 'rapid assessment' provisions of the Hazardous Substances and New Organisms (HSNO) Act gives the Authority of ERMA New Zealand, the power to delegate decision-making on low-risk genetically modified organisms (GMOs) to certain institutions.

Most delegations are to institutions, such as universities and crown research institutes. These delegated institutions have set an Institutional Biological Safety Committee (IBSC) for the purpose of considering low-risk GMO import and development applications. The delegation covers the development and import of genetically modified organisms that meet the low-risk criteria in laboratory and research situations within contained facilities.

This excludes the power to consider applications on genetically modified human embryos and human embryonic stem cells.

The definition of low-risk genetic modifications is contained in the HSNO (Low-Risk Genetic Modification) Regulations 2003.

What does an Institution with such a delegation have to do?

The Chief Executive or Vice Chancellor of an Institution with delegated authority must:

  • Set up an Institutional Biological Safety Committee (IBSC) to assess applications for development in containment or importation into containment of low risk genetically modified organisms;
  • Provide the IBSC with resources and facilities it needs to operate effectively;
  • Recognise the role of the IBSC and give it the authority and support it needs to do its job;
  • Encourage compliance within the Institution;
  • Ensure decisions are made by the Committee in a timely and responsible manner.

Members of the IBSC

The members of an IBSC must have the expertise required to assess the applications brought before them. Membership must comprise of:

  • A chairperson;
  • A Biological Safety Officer (BSO) who is not the chairperson;
  • A layperson not associated with the Institution that is able to consider community interests;
  • A microbiologist;
  • A molecular biologist and/or geneticist or ecologist;
  • (A) mandated Māori representative(s) (unless exemption applies).

Biological Safety Officers

The IBSC is responsible for appointing a Biological Safety Officer (BSO) who should have experience working with containment facilities and has responsibility for notifying any IBSC membership changes to the Authority.

How to obtain delegated decision making power from the Authority

To obtain delegated power from the Authority to approve low risk GMO developments and importations, the Chief Executive or Vice Chancellor of the Institution must be able to show that the Institution meets all the criteria.

For further information refer to:

Once the Authority is satisfied the IBSC meets the required criteria, a delegation document will be issued which will provide the terms of the delegation.

The cost for Institutions applying for delegated authority to conduct rapid assessments for development in containment and importation into containment of low risk GMOs is $500 + GST. This fee applies irrespective of the number of applications expected to be considered by the Institution and applies over the life of the delegation.

Renewal of IBSC delegation

The Authority sets the duration of the delegation. Before the delegation is due to expire, the Chief Executive or Vice Chancellor of the Institution must apply for renewal of the delegation. Again, the IBSC must be able to show that each of the criteria is met. The cost for renewing listed in ERMA New Zealand's Fees and Charges Schedule

Making an application to an IBSC

An applicant can make an application to their IBSC to develop in containment (section 42 and 42A) and import into containment (section 42B) low-risk genetically modified organisms as defined in the HSNO (Low-Risk Genetic Modification) Regulations 2003.

Application Forms:

User Guides:

Making an Amendment to a decision (minor or technical amendment)

The Authority has also delegated powers to IBSCs to make amendments to decisions under section 67A of the HSNO Act. For guidance on what constitutes a minor or technical amendment see Making an Amendment to a Decision .

Application Form

On the Proposal for Amendment form the IBSC should assign the original Institution code but include s67A at the end ie GMO06/XX001 s67A. The Proposal for Amendment form should NOT be used to add new host species or for experiments that are outside the scope of the original purpose. This will require a NEW application. When submitting a s67A amendment request the original application, decision document and Proposal for Amendment form must all be provided to the IBSC decision-making committee.

When the amendment is approved by the Committee, the original decision should be redrafted as indicated in the latest decision form rather than start with the current decision form.  An amended decision will not be allocated new approval codes or BCH numbers. These remain the same.

Decision Form and Checklist

IBSCs are required to fill out the following decision forms and checklists:

Confidential information should be clearly marked as such, and attached to the application or decision form as a separate appendix and referenced in the decision or application form.

Making an IBSC decision

IBSCs are required to assess applications within 10 working days of formal receipt of the application or Proposal for Amendment.

These documents should be forwarded to ERMA New Zealand within 10 working days of the date the IBSC decision and checklist is signed.
For standard applications send electronic copies of the decision form and checklist, and for s67A amendments send electronic copies of the proposal for a s67A, the new decision form and checklist, and ideally the old decision form

to: IBSC@ermanz.govt.nz

Post a signed copy of the completed decision form and checklist along with the application for standard applications, and for s67A amendments, send a signed copy of the proposal for a s67A, and the new and old decision forms and checklists.
to:
ERMA New Zealand,
PO Box 131,
Wellington
Attention: Dr Libby Harrison, General Manager, New Organisms Group

Who can use an approval made by an IBSC?

An approval given by an IBSC is "applicant specific" meaning only the applicant (which in many cases is an organisation) is entitled to perform the development or importation. The approval is also site specific and may not be used at any other centre unless this is specifically recognised in the approval.

What happens to the decision at ERMA New Zealand?

Because these decisions are made under delegated authority, IBSCs are required to demonstrate that they have followed the provisions of the HSNO Act 1996, the HSNO (Methodology) Order 1998, the HSNO (Low-Risk Genetic Modification) Regulations 2003 and relevant protocols issued by the Authority. Once ERMA New Zealand has received the decision form, it is entered into our database and given an ERMA New Zealand application code (5 digits). The application form and decision are checked against the HSNO Act, the Methodology and the Low-Risk Regulations to ensure compliance with their delegation.

If ERMA New Zealand is satisfied with the decision the organisms are then given approval numbers (6 digits). Each decision received by ERMA New Zealand is then published on our Register and in the next Bulletin in summary form.

Copies of all IBSC decisions and applications are stored in the Register at ERMA New Zealand. For Proposal for Amendments, the original decision will be removed from our Register and replaced with the new decision.

Maori Membership of Institutional Biological Safety Committees (IBSCs) and Consultation Requirements with the Maori Community

See Maori Membership of Institutional Biological Safety Committees (IBSCs) and Consultation Requirements with the Maori Community

Contact at ERMA New Zealand

If you have any questions regarding IBSCs please contact ERMA New Zealand: IBSC@ermanz.govt.nz