Make an application
Here you'll find information about the different types of new organism applications you can make, the application process, and the form to use.
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New organism applications
There are two basic types of new organism applications:
- Application to hold the new organisms in an approved containment facility (such as laboratories, glasshouses, zoos or field test sites).
- Application to release the new organism into the environment.
We recommend you contact us by phone on 0800 CALLEPA (0800 225 537) or email us at neworganisms@epa.govt.nz before completing an application form.
Consulting with Māori
In some cases, you need to provide evidence of how you have taken Māori perspectives into account for your application. The information about specific applications below will tell you if you will need to go through this process for your application. If you do, please contact us by phone 0800 CALLEPA (0800 225 537) or email neworganisms@epa.govt.nz to discuss it with us.
Application costs
There may be fees associated with your new organism application.
Supplying confidential or commercially sensitive information under the HSNO Act
We collect such information as part of our work to assess and manage the risk of introducing new organisms into New Zealand.
While we have a responsibility to you to store the confidential or commercially sensitive information you provide safely, we also have a responsibility to the general public.
So if we receive a request under the Official Information Act 1982, generally, we must make it available unless there is a good reason to withhold that information which is not outweighed by the public interest.
Read protections available for your confidential and commercially sensitive information.
Determine if an organism is new
You can make an application to formally (eg. legally) determine whether an organism should be classed as a new organism or not.
Providing evidence
You must provide evidence that the organism was present in the New Zealand environment before July 29 1998. Evidence can include:
- Signed declarations from experts handling or growing the organism prior to this date.
- Import approvals from the Ministry for Primary Industries, or sales or exhibition catalogues.
- Signed statements from recognised authoritative experts.
- Scientific papers or evidence that the organism has been isolated in New Zealand.
Consulting with Māori
You do not need to consult with Māori.
Public notification of application
This type of application is not publicly notified.
Application process timeframe
There is no statutory timeframe for processing this application.
New organisms in containment – importation
You can apply to import new organisms, including genetically-modified organisms (GMOs), into containment in New Zealand.
Find out more about containment
Rapid assessment
You can request that your application to import GMOs into containment undergoes a rapid assessment. Low risk genetic modifications are those that meet the criteria listed in the Hazardous Substances and New Organisms (Low-Risk Genetic Modification) Regulations on the New Zealand Regulations website.
The decision to undertake a rapid assessment is made after the formal receipt of your application.
Containment application form (DOCX, 378KB)
Containment application form (PDF, 271KB)
Consulting with Māori
You may need to engage with Māori for this type of application.
Public notification of application
Rapid assessments are not publicly notified.
Our Chief Executive will decide if your application should be publicly notified if there will be significant public interest in it. This decision is made after your application is formally received.
Application timeframe
Rapid assessments: a decision is usually made within two weeks from the formal receipt of the application.
View the statutory timeline for a rapid assessment application (PDF, 2.4MB)
Non-notified applications: a decision is usually made between 1.5 and 3 months from the formal receipt of your application.
View the statutory timeline for a non-notified application (PDF, 148KB)
Publicly-notified applications: a decision is usually made between 6 to 9 months from the formal receipt of this type of application.
View the statutory timeline for a notified application (PDF, 171KB)
New organisms in containment – development (production, fermentation and regeneration)
Developments are the production of a GMO or the fermentation or regeneration of a new organism (GMO or non-GMO).
Production
The production of a genetically modified organism (GMO) means using in vitro techniques to modify the genes or genetic material of an organism (host organism). Genetic material includes any genes, nucleic acids or other molecules that are heritable and can transfer a character or trait to another organism or subsequent generations. The GMOs are to be developed and held in approved indoor or outdoor containment facilities.
Fermentation
Fermenting is the liquid culturing or “bulking up" of new microorganisms—for example, growing bacteria in flasks. Fermentation always occurs in approved indoor containment facilities such a commercial or research laboratory.
In most cases, a separate fermentation approval is not required if you already have approval to import the microorganism into containment, and the fermentation involves volumes less than 10L/vessel. An additional fermentation approval is required for volumes greater than 10L/vessel even if you have an existing approval to import the microorganism.
Regeneration
Regeneration is the production of a new organism from biological material through human involvement, ie. cloning. A theoretical example is cloning a dinosaur from the marrow of dinosaur bones. Regenerating a new animal only requires approval if the animal from which the biological material is sourced is classed as a new organism in New Zealand. For example, cloning a cow from the biological material of cows already present in New Zealand does not require approval from us.
Approvals for low risk GMOs
If you want to produce, ferment or regenerate a GMO that is low risk and your activity is a project, your application may be eligible to undergo rapid assessment. Low risk genetic modifications are those that meet the criteria listed in the Hazardous Substances and New Organisms (Low-Risk Genetic Modification) Regulations on the New Zealand Regulations website. These regulations look at the characteristics of the modified organism, the proposed genetic modifications, and where the research will occur to determine if it is low risk.
Developments that take place in outdoor containment facilities, do not fall under the "low risk" criteria.
Containment - GMO project application form (docx 377KB)
Containment - GMO project application form (pdf 271KB)
Approvals for non-low risk GMOs and new organisms
If your application involves GMOs that do not fall under the low risk criteria or is for new organisms, use this form:
Containment application form (docx 378KB)
Containment application form (pdf 271KB)
Consulting with Māori
You may need to engage with Māori for this type of application.
Read our guidance on consultation for applicants.
Public notification of application
Rapid assessments are not publicly notified.
Our Chief Executive will decide if your application should be publicly notified if there will be significant public interest in it. This decision is made after your application is formally received.
Application process timeframe
Rapid assessments: an assessment is made within two weeks from the formal receipt of the application.
View the statutory timeline for a rapid assessment application (pdf 2.47MB)
Non-notified applications: a decision is usually made between 1.5 and 3 months from the formal receipt of your application.
View the statutory timeline for a non-notified application (pdf 353KB)
If your application is publicly notified, a decision is usually made between six to nine months from the formal receipt of this type of application.
View the statutory timeline for a notified application (pdf 704KB)
Release new organisms with controls
An application to release with controls can cover a wide range of circumstances from a scientific trial at one end of the range, to an almost unregulated release at the other. The new organism is released into the New Zealand environment but will have some restrictions that must be adhered to (called controls). After approval has been given, the released organism is still classed as a new organism and can only be used as specified in the approval.
Application Form - Release with Controls (docx 373KB)
Consulting with Māori
You will need to engage with Māori for this type of application. You can contact us for guidance on this.
Read our guidance on consultation for applicants.
Public notification of application
An application to release new organism with controls must be publicly notified and is open for public submission.
Application process timeframe
A decision is usually made between six to nine months from the formal receipt of the application.
View the statutory timeline for a notified application (pdf 353KB)
Release new organism without controls
An approval to release without controls means new organisms (including GMOs) can be released into the New Zealand environment without any restrictions.
The released organism:
- is no longer regulated under the HSNO Act
- is not classed as a new organism, and
- does not need any further approvals from us.
Examples of organisms approved for release without controls include biological control agents and a range of microorganisms for various purposes.
Release application form (docx 375KB)
Rapid assessment
If your application is for an import for release and your organism meets the following criteria, it may qualify for rapid assessment.
The new organism:
- is not an unwanted organism as defined in the Biosecurity Act.
- must not be genetically modified.
- must not establish a self-sustaining population (taking into account ease of eradication).
- must not displace or reduce a valued species, must not cause deterioration of natural habitats.
- must not be a disease-causing or be a vector for human, plant or animal disease.
- must not have any adverse effects on human health and safety or the environment
You may request that your application for non-GM organisms be assessed down this route (see section 6 of the application form). This decision would be made after the formal receipt of your application.
If your organism does not qualify for rapid assessment, the application will be assessed as a release application. Please contact us about this.
Consulting with Māori
You will need to engage with Māori for this type of application. You can contact us for guidance on this.
Read our guidance on consultation for applicants.
Public notification of application
Rapid assessments are not publicly notified.
If your application is not rapidly assessed, the application must be publicly notified and is open for public submission.
Application process timeframe
Rapid assessments: an assessment is made within two weeks from the formal receipt of the application.
View the statutory timeline for a rapid assessment application (pdf 2.47MB)
If your application is not rapidly assessed, a decision is usually made between six to nine months from the formal receipt of the application.
View the statutory timeline for a notified application (pdf 704KB)
Make an amendment to a new organism approval
Amendments
An amendment allows changes to a new organism approval after it has been given — but only if the change is minor in effect, or corrects a minor or technical error. For example:
- Changes to the approved organism description that do not change the overall risks.
- Correcting typographical or drafting errors.
- Adjusting existing controls to make them more practical, workable or enforceable.
Note: to amend an approval given by the Institutional Biological Safety Committee (IBSC), please contact the approving IBSC.
Proposal Form - Apply for an amendment (doc 380KB)
What is the approved organism description?
An “approved organism description” lists what organism(s) an approval to import, develop, field test or release is for. An approved organism description may specify only one organism or a range of organisms.
What are controls on new organism approvals?
An approval is given controls by the decision-makers to eliminate or manage potentially significant adverse risks. For example, controls for a containment approval may require that the organism is held within a secure facility and only handled within a class II hood. Controls for a release approval may require that only sterilised males are released.
Consulting with Māori
You may need to engage with Māori for this type of application.
Read our guidance on consultation for applicants.
Public notification of application
A proposal to make an amendment is not open for public submission.
Application process timeframe
There is no statutory timeframe to process a proposal for an amendment. However, we will endeavour to process your proposal in a timely manner.
Release new organisms with controls by rapid assessment
An approval to release a new organism with controls by rapid assessment means the organism can be released into the New Zealand environment but with some restrictions (called controls) that must be adhered to. Even though it has been released, the organism remains a new organism and can only be used in the way specified in the approval.
To apply for a release by rapid assessment, the new organism:
- must not be genetically modified.
- must not establish a self-sustaining population (taking into account ease of eradication).
- must not displace or reduce a valued species.
- must not cause deterioration of natural habitats.
- must not be a disease-causing or be a vector for human, plant or animal disease.
- must not have any adverse effects on human health and safety or the environment.
Application Form - Release with Controls EPA0323 (docx 373KB)
Is this the right application type?
If your organism will establish a self-sustaining population, you do not qualify for rapid assessment and should apply to release a new organism with controls.
Controls on new organism approvals
An approval is given controls by the decision-makers to eliminate or manage potentially significant adverse risks. For example, controls for a containment approval may require that the organism is held within a secure facility and only handled within a class II hood. Controls for a release approval may require that only sterilised males are released.
Self-sustaining populations
A self-sustaining population could be defined as one that can replenish itself over a period of time. The characteristics of a self-sustaining population can be organism-dependent. Rats and possums are examples of animals that have formed self-sustaining populations throughout New Zealand.
Consulting with Māori
You will need to engage with Māori for this type of application. You can contact us for guidance on this.
Read our guidance on consultation for applicants.
Public notification of application
An application to release a new organism with controls by rapid assessment is not publicly notified.
Application process timeframe
An assessment is made within two weeks from the formal receipt of the application.
View the statutory timeline for a rapid assessment application (pdf 2.47MB)
Release new organisms without controls by rapid assessment
An approval to release by rapid assessment means the organism can be released into the New Zealand environment without any requirements (called controls) attached.
The released organism:
- is no longer regulated under the HSNO Act;
- is no longer classed as a new organism; and
- does not need any further approvals from us.
To apply for a release by rapid assessment, the new organism:
- must not be genetically modified.
- must not establish a self-sustaining population (taking into account ease of eradication).
- must not displace or reduce a valued species. must not cause deterioration of natural habitats.
- must not be a disease-causing or be a vector for human, plant or animal disease.
- must not have any adverse effects on human health and safety or the environment.
Application Form - Release EPA0322 (docx 375KB)
Is this the right application type?
If your organism will establish a self-sustaining population, you do not qualify for rapid assessment and should apply to release a new organism without controls.
What is a self-sustaining population?
A self-sustaining population could be defined as one that can replenish itself over a period of time. The characteristics of a self-sustaining population can be organism-dependent. Rats and possums are examples of animals that have formed self-sustaining populations throughout New Zealand.
What are controls on new organism approvals?
An approval is given controls by the decision-makers to eliminate or manage potentially significant adverse risks. For example, controls for a containment approval may require that the organism is held within a secure facility and only handled within a class II hood. Controls for a release approval may require that only sterilised males are released.
Will I need to consult with Māori about my proposed application?
Yes. We can provide guidance on this.
Read our guidance on consultation for applicants.
Will the application be publicly notified?
No. An application to release a new organism without controls by rapid assessment is not publicly notified and is not open for public submission.
How long will the application take to process?
A decision is usually made within 2 weeks from the formal receipt of the application.
View the statutory timeline for a rapid assessment application (pdf 2.47MB)
Times may vary depending on how complex the application is.
What is the application fee?
Please refer to our Fees Schedule for the current fee for this application
Release a medicine containing a new microorganism by rapid assessment
You can apply for an animal or human medicine that is, or contains a live low risk new or genetically modified (GM) microorganism to be imported and used in New Zealand.
To qualify for a rapid assessment, the microorganism must:
- be used as a medicine or contained within a medicine
- at the dose and routes of administration used, not cause significant adverse effects on public health and the environment, and
- not be able to form an undesirable self-sustaining population that would have significant adverse effects on public health and the environment.
An application to release a medicine can be approved with or without controls. If approval is given with controls, the microorganism still remains a new organism and can only be used in the medicine the approval is for.
You may request that your application for new organisms be assessed down this (rapid assessment) route (see section 6 of the application form). This decision would be made after the formal receipt of your application.
If your organism does not qualify for rapid assessment, the application will be assessed as a release application. Please contact us about this.
Other approvals
Approval may also be required under other Acts where relevant (eg. Medicines Act 1981, Agricultural Compounds and Veterinary Medicines Act 1997, Biosecurity Act 1992).
Go to Medsafe website for requirements to import a new human vaccine
Go to ACVM website for requirements to import a new animal vaccine
Go to MPI website for requirements to import a live microorganism
Release application form (docx 375KB)
Consulting with Māori
You may need to engage with Māori for this type of application.
Read our guidance on consultation for applicants.
Public notification of application
Rapid assessments are not publicly notified.
Application timeframe
Rapid assessments: a decision is usually made within two weeks from the formal receipt of the application.
View the statutory timeline for a rapid assessment application (pdf 2.47MB)
Field test new organisms in outdoor containment
A field test is an outdoor trial for investigative research where the new organisms will be exposed to similar conditions they would experience should they be released. The organisms and all biological material must be restricted to the field test site and are considered to be kept in containment.
A field test must fulfil three criteria:
- it must involve the carrying on of trials on the effects (either positive or negative) of the new organisms
- it must occur under conditions similar to those of the environment into which the new organisms are likely to be released
- the new organisms or any heritable material arising from them can be retrieved or destroyed at the end of the field test.
Application Form - Containment EPA0324 (docx 371KB)
Consulting with Māori
You may need to engage with Māori for this type of application.
Read our guidance on consultation for applicants
Public notification of application
Our Chief Executive will decide if your application should be publicly notified if there will be significant public interest in it. This decision is made after your application is formally received.
Application timeframe
If your application is not publicly notified, a decision is usually made between 1.5 to 3 months from the formal receipt of the application.
View the statutory timeline for a non-notified application (pdf 353KB)
If your application is publicly notified, a decision is usually made between six to nine months from the formal receipt of the application.
View the statutory timeline for a notified application (pdf 704KB)
Release new or genetically modified organisms in an emergency
An application to release a new organism in an emergency means a new organism or genetically modified organism (GMO) can be held in an approved containment facility in New Zealand and then only used if the emergency (specified in the application) occurs. The new organism or GMO can only be released once the emergency has been formally declared by a person with the authority to do so.
An example is a vaccine (that contains a new organism or GMO) for a disease that is not currently in New Zealand but there is possibility that it may arrive. The vaccine is imported and held in New Zealand for future disease management should the disease occur. The organism is still classed as a new organism — even after it has been released — and cannot be used beyond the scope of the approval.
Approval may also be required under other Acts where relevant (eg. Medicines Act 1981, Agricultural Compounds and Veterinary Medicines Act 1997, Biosecurity Act 1992).
Go to Medsafe website for requirements to import a new human vaccine
Go to ACVM website for requirements to import a new animal vaccine
Application Form - Emergency release (pdf 123KB)
Is this the right application form?
This application is used when the emergency — and the use of the new organism in that emergency — is foreseeable and management options need to be in place should the emergency occur. If you need to release a new organism urgently in response to the emergency, you need to make an application to release a new organism in a special emergency.
Application to release a new organism or a GMO in a special emergency
Consulting with Māori
You will need to engage with Māori for this type of application. We can provide guidance on this.
Read our guidance on consultation for applicants.
Public notification of application
An application for a release in an emergency must be publicly notified and is open for public submission.
Application timeframe
A decision is usually made between six to twelve months from the formal receipt of the application.
View the statutory timeline for a notified application (pdf 704KB)
Release new or genetically modified organisms in a special emergency
What is an emergency?
An emergency is:
- an event involving the release of a new organism for which a national pest management strategy has been approved under section 68 of the Biosecurity Act 1993; or
- a state of emergency declared under the Civil Defence Emergency Management Act 2002; or
- an emergency as defined in section 2 of the Fire Service Act 1975; or
- an emergency declared under Part IX of the HSNO Act; or
- a marine oil spill emergency under the Maritime Transport Act 1994.
Release new or genetically modified organisms in a special emergency
An approval to release in a special emergency is a fast-tracked approval that allows a new organism or genetically modified organism (GMO) to be used in New Zealand when an emergency occurs.
The application is made in response to the declaration of a special emergency by a person with the authority to do so. For example, if the Minister for Primary Industries declared a special emergency due an outbreak of a new cow disease, a special emergency approval could allow the importation and use of a vaccine (containing a live GM virus) to control the spread of the disease.
Application Form - Special emergency release (doc 403KB)
Is this the right application form?
If you need to release a new organism or GMO urgently, then the application form above is the right one. If the emergency is foreseeable and you have time to plan for it, you need to make an application to release a new organism or GMO in an emergency.
Application to release a new organism or GMO in an emergency (doc 398KB)
Consulting with Māori
You won't need to engage with Māori for this type of application.
Public notification of application
An application for a release in a special emergency is not publicly notified.
Application timeframe
A decision is given priority and made under urgency.
Tranship a new or genetically modified organism through New Zealand
An application to tranship new organisms or genetically modified organisms (GMOs) in New Zealand is used solely for importing a new organism into New Zealand and then exporting it again within 20 working days (ie. in transit). Repackaging or any form of use is not permitted.
Transhipment of a prohibited organism is also not permitted.
If the new organisms or GMOs will be in New Zealand longer than 20 working days, you need to apply to import the new organisms or GMOs into a containment facility. The containment facility must be approved by the Ministry for Primary Industries.
Transhipment of New Organism application form (docx 371KB)
Consulting with Māori
You won't need to engage with Māori for this type of application.
Public notification of application
An application to tranship new organisms or GMOs in New Zealand is not publicly notified.
Application timeframe
A decision is usually made within 10 working days from the formal receipt of the application
Reassessment of a new organism approval
A reassessment involves having a second look at the risks and benefits identified in an application that was previously approved. This only applies to approvals where the organism remains a new organism, eg. approvals for containment or release with controls. The reassessment may result in changing the controls of the approval, or in extreme cases, result in the withdrawing of the approval.
Read more about the reassessment process
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Contact the team
Get in touch with us to make an application.
Consulting with Māori
We have information and guidance about consulting with Māori about your application.