New Organisms (and Hazardous Substances)

Why are new organisms and hazardous substances regulated?

A range of species introduced into New Zealand in the past (such as possums and gorse) have had very damaging environmental effects, and some substances also have caused, or have the potential to cause, significant adverse effects on human health and/or the environment. The Hazardous Substances and New Organisms (HSNO) Act 1996 requires that new organisms and hazardous substances now receive greater scrutiny for potential harm that they may cause before they are introduced, released, or used here.

The HSNO Act was established to manage or prevent risk to people and the environment through the use of hazardous substances (such as pesticides and explosives) and new organisms.

How are new organisms and hazardous substances and regulated in New Zealand?

Anyone wishing to import or manufacture a new hazardous substance, or to import, develop, field-test or release a GMO or any other organism that is "new" to New Zealand must make an application to the Environmental Risk Management Authority of New Zealand (the Authority), or another body which has received delegated decision-making powers from the Authority (such as an Institutional Biological Safety Committee at a research institute, or the Chief Executive of ERMA New Zealand – the Agency set up to assist the Authority). More information on the Authority or ERMA New Zealand is available in the "Who is involved?" section of the Regulatory Wayfinder.

For new organism applications other than full release, the Authority can impose conditions on how the new organisms are to be contained, used, monitored, destroyed, etc. Ensuring compliance with such conditions is the responsibility of MAF Biosecurity New Zealand, which is a division of the Ministry of Agriculture and Forestry (MAF).

Importation, manufacture, and use of hazardous substances will generally require controls so that they are handled, used and managed safely. Importation or use of a new organism or hazardous substance without an approval or failure to meet the conditions on an approval can result in fines and/or imprisonment.

The decision-making framework of the Authority consists of the HSNO Act, a broad statement of principles, policy and processes (set out in its Methodology), and other protocols and supporting material developed to describe information requirements and application consideration processes.

Note - Most of the information on the Regulatory Wayfinder concerns new organisms rather than hazardous substances. We provide only introductory information on the regulation of hazardous substances at the moment. If you are interested in detailed information on the regulation of hazardous substances please go to the ERMA New Zealand website.

What is regulated?

Some organisms are prohibited from being introduced into New Zealand. These prohibited organisms are listed in Schedule 2 of the HSNO Act, and include venomous spiders, as well as a variety of other venomous, poisonous, or pest plants and animals.

New organisms

Organisms which were not present in New Zealand immediately before the HSNO Act came into effect (29 July 1998) are considered "new" and require an approval to be imported, developed, field tested or released in New Zealand. Organisms that have been approved for full release in New Zealand are no longer considered new.

Genetically modified organisms (GMOs) are considered to be new organisms. Genetic modification involves the laboratory manipulation of genetic material and its introduction into an organism. For example, putting the gene that produces human insulin into a laboratory bacterium, or introducing a gene for tolerance to a herbicide into a corn plant, creates a GMO. Crossing different types of GMOs can also result in the creation of a new organism and so is also regulated. For example, an approval will be required to breed two different strains of GM mice together.

For those interested in biotechnology GMOs are likely to be of most interest, but some non-modified "new" organisms used for fermentation or other applications will also require approval if they are new to New Zealand.

Hazardous substances

A new hazardous substance is one that triggers the HSNO Act hazardous property thresholds defined in the Hazardous Substances (Minimum Degrees of Hazard) Regulations and does not have a current approval. ERMA New Zealand has produced a user guide to the thresholds and classifications under the HSNO Act, and an information sheet on whether an approval is needed.

"Small-scale" research and development or teaching involving hazardous substances can be exempt from an approval if the research is conducted in a laboratory meeting prescribed requirements. Small-scale use is not explicitly defined so discuss with ERMA New Zealand whether your research is exempt (phone on 0800 376 234 or email hsinfo@ermanz.govt.nz). An information sheet on exemptions for small-scale use is also available.

If you are not sure if a particular substance is a hazardous substance look at information on ERMA New Zealand's website and/or contact ERMA New Zealand (phone on 0800 376 234 or email hsinfo@ermanz.govt.nz). You can apply to the Authority or ERMA New Zealand for a formal determination or non-statutory advice as to whether or not a substance is hazardous.

What is not regulated?

New organisms

Once a new organism has been approved for full release in New Zealand it is no longer considered "new" and is not regulated under the HSNO Act.

The genetic modification of human beings is regulated under the Human Assisted Reproductive Technology (HART) Act 2004. However the genetic modification of cells or tissues derived from humans (which includes reproductive cells grown or maintained outside the human body) is regulated under the HSNO Act.

Genetic modification does not cover traditional breeding techniques such as hybridisation between species through pollination or other normal means of reproduction, or regenerating plants from tissue. Some other plant breeding techniques that introduce random genetic changes are not considered to result in genetically modified organisms, and so are not regulated by the HSNO Act. These techniques, which mimic natural processes, include use of chemicals or radiation to cause mutations in plants. Mutants with desired characteristics are selected and can be further developed using normal plant breeding techniques. More information on what is not considered genetic modification can be found in the HSNO (Organisms Not Genetically Modified) Regulations 1998.

Cloned animals in themselves are not considered to be genetically modified or "new" organisms as long as they are derived from organisms that are not "new" (eg, not derived from GMOs). Their development may, however, require approval from an animal ethics committee.

Plants, animals or micro-organisms that arrive in New Zealand unintentionally (such as by flying or floating) after July 29 1998 are new organisms and therefore subject to the HSNO Act. In addition, if they are considered a pest (such as a disease-carrying mosquito, or an invasive plant) then they may be subject to control under the Biosecurity Act 1993. Organisms incidentally imported on or in goods imported under the Biosecurity Act are not regulated by the HSNO Act unless they become established in the environment.

Hazardous substances

Many substances will not be classed as "hazardous" because they are not explosive, flammable, able to oxidise, corrosive, toxic or eco-toxic, or they do not exceed the thresholds set for these properties and therefore are not regulated under the HSNO Act.

Manufactured articles that contain a hazardous substance (such as a battery) are not considered substances under the HSNO Act unless they have explosive properties.

Radioactive substances are not covered by the HSNO Act unless they also have other hazardous properties. Radioactive substances will probably come under the provisions of the Radiation Protection Act 1965.

Medicines that involve hazardous substances are, with some exceptions, exempt from provisions of the HSNO Act. Foods in a ready to eat form are not classified as hazardous substances, but food additives that are hazardous substances and that have not been added or mixed with foods are not exempt from provisions of the HSNO Act. Contact ERMA New Zealand (phone on 0800 376 234 or email hsinfo@ermanz.govt.nz) for more information on these.

What is the regulatory process?

New Organisms

A quick guide to the regulatory process for new organisms is available from ERMA New Zealand.

The regulatory process undertaken will depend on the type of new organism and the purpose for which it is required (eg, to be kept within a laboratory or used in the open environment). The more significant or complex an application is, the more information that will need to be provided, and the longer the assessment process will be. Some of the application types (such as field tests) are required to be publicly notified.

A brief summary of the types of new organisms applications

More information on specific application types can be found at the ERMA New Zealand website or through contacting ERMA New Zealand.

Application type What this application covers Indicatory process
This column outlines the typical processing timeframes – however time frames may be extended for complex applications. Talk to ERMA New Zealand for confirmation about the most appropriate application type and expected timeframes.
Determination of whether an organism is a new organism A determination is when a statutory decision is made about whether an organism is a "new" organism (and therefore if it is regulated under the HSNO Act) (section 26 of the HSNO Act). This application type has no statutory time requirements but is processed as soon as practicable. This application type is not publicly notified.
Transhipment of a new organism A "transhipment" is when a new organism is imported into New Zealand that will be sent to another country within 20 working days, ie the organism is in transit through New Zealand. An example would be where wombats being shipped from Australia to the USA are required to change ship in New Zealand (section 51 of the HSNO Act). Application is usually processed within 2 weeks of application receipt. This application type is not publicly notified.
Import into containment of a new organism Imports into containment are where new organisms are brought into New Zealand and kept in a containment facility (such as a genetically modified bacterium that is kept in a laboratory, or an exotic animal kept into a zoo) (sections 39, 40, 42B, 44, and 45 of the HSNO Act).

Imports of new organisms will also require a MAF Import Permit. See the section on MAF Import Permits below 		This application type may or may not be publicly notified depending upon what activities are applied for.

If publicly notified, this application type is typically processed within 6-9 months of application receipt.

If not publicly notified, this application type is typically processed within 3-4 months of application receipt.

If the application fulfils the criteria of a low risk GM application and other criteria, it may undergo rapid assessment. This application type is typically processed within 2 weeks of application receipt. Rapid applications are not publicly notified
Development in containment of a new organism Developments are where a GMO is created in New Zealand within a registered containment facility. Large scale fermentation or liquid culture of a new micro-organism, and where a new organism is regenerated (eg through cloning) are also considered to be developments (sections 39, 40, 42, 42A, 43, 44A, 45 and 45A of the HSNO Act).

For developments of GMOs you can apply to develop a group of GMOs that are to be used for the same project in the same application. If you intend to breed different types of GMOs then a development application needs to include or be made to cover this.

An outdoor development is where approval is given to contain the new organism in a containment facility (such as a research farm) that is not a fully enclosed laboratory. 		This application type may or may not be publicly notified depending upon what activities are applied for.

If publicly notified, this application type is typically processed within 6-9 months of application receipt.

If not publicly notified, this application type is typically processed within 3-4 months of application receipt.

If the application fulfils the criteria of a low risk GM application and other criteria, it may undergo rapid assessment. This application type is typically processed within 2 weeks of application receipt. Rapid applications are not publicly notified.
Field test of a new organism A field test is to used to evaluate a new organism under conditions similar to those of the environment into which the organism is likely to be released but from which the organism, or any heritable material arising from it, can be retrieved or destroyed at the end of the field test (sections 39, 40, 44, 44A, 45 and 45A of the HSNO Act). This application type is typically processed within 6-9 months of application receipt. This application type is publicly notified.
Release approvals A release is where the new organism is intended to be released into the environment and where it may not be possible to contain or recover all viable heritable material (whole plants, animals, bacteria, pollen, eggs, seeds, etc).

Applications for release have to meet high levels of assurance that they will not have significant adverse effects on humans or the environment, and that the benefits of their release outweigh any risks. An approval to release a new organism cannot be given if it does not meet minimum standards (section 36 of the HSNO Act). 		See below for the specific types of applications.
Rapid release of a new organism A rapid release is the release of non-GMOs that are considered low risk (such as some non-weedy and non-toxic garden plants) and cannot form a self-sustaining population (taking into account ease of eradication). The criteria for such organisms being considered low-risk are given in section 35 of the HSNO Act. This rapid assessment application type is typically processed within 2 weeks of application receipt. Rapid applications are not publicly notified.
Rapid release of a new organism that is or contained within a medicine or veterinary medicine (qualifying organism) A qualifying organism is a new organism that is or contained within certain human medicines and veterinary medicines that poses little risk to humans and the environment (sections 38I to 38L of the HSNO Act). ERMA New Zealand also has an information sheet available This rapid assessment application type is typically processed within 2 weeks of application receipt. Rapid applications are not publicly notified.
Conditional release of a new organism A conditional release is where certain requirements are imposed on the released organism. These may be restrictions on where or when or how the organism can be grown or released, monitoring of impacts or spread of the organism, having border rows and specific management regimes for a crop, or other factors that the Authority considers relevant (sections 38A to 38H of the HSNO Act). This application type is typically processed within 6-9 months of application receipt. This application type is publicly notified
Full release of a new organism A full release is where no conditions are made on the approval - the organisms can be grown or released as desired. A fully released organism is no longer a new organism (sections 34 to 38 of HSNO Act). This application type is typically processed within 6-9 months of application receipt. This application type is publicly notified
Use of a new organism in an emergency This application type is used when an applicant wishes to release a new organism for use in a foreseeable emergency (sections 46 to 49 of the HSNO Act). An "emergency" is defined in section 46 of the HSNO Act. This application type undergoes a similar process to a conditional release application. This application type is typically processed within 6-9 months of application receipt. This application type is publicly notified
Use of a new organism in a special emergency This rapid application type is used when an applicant wishes to release a new organism for use in a foreseeable or unforeseeable special emergency (sections 49A to 49L of the HSNO Act). A "special emergency" is defined in section 49B of the HSNO Act. This application type has no statutory time requirements; however this application type is processed as rapidly as possible. This application type is not publicly notified
Reassessment of an existing approval Anyone may request that the Authority consider whether there are grounds for reassessing an approval for a new organism. The Authority will decide that there are grounds to reassess a new organism only if significant new information relating to the effects of the organism has become available (section 62 of the HSNO Act).

If there are grounds for reassessment then the reassessment is treated as a new application (section 63 of the HSNO Act).

A reassessment may result in the original approval being declined, changes being made to controls on the original approval, or no changes being made to the original approval. 		A "grounds for reassessment" application type has no statutory time requirements but is processed as soon as practicable. This application type is not publicly notified.

If grounds for reassessment are found, the application is treated as a new application.
Amendment of an existing approval Researchers can request amendments to existing approvals if these changes are considered to be minor or technical amendments (via section 67A of the HSNO Act).

For example, an amendment could be made to enable use of DNA from a different species in a project, to use a different cloning vector, or to refine or correct a control listed in the original approval. 		This application type has no statutory time requirements but is processed as soon as practicable. This application type is not publicly notified.

Involving Maori in the process

An important aspect of the HSNO Act is the requirement to discuss certain types of application with Maori before they are submitted to ERMA New Zealand (for example if genetic material from native or valued flora and fauna is proposed to be used). Talk to ERMA New Zealand about whether your application will require consultation or look at the user guide on working with Maori.

Application costs

The costs associated with submitting applications depend on the application type. Click here for information on the fees for all application types.

Who makes the decisions?

The Authority makes the decisions on applications under the HSNO Act. However for decisions on rapid GMO development or import assessment applications, the Authority may delegate the decision-making to others, for example to the Chief Executive of ERMA New Zealand. In addition, research organisations can seek permission from ERMA to establish an institutional biological safety committee (IBSC) to assess and make decisions on low risk GMO import and development applications for their institute. Where an institute does not have an IBSC, the Chief Executive of ERMA New Zealand can perform the assessment and decision-making.

How can I find out about decisions?

All decisions made by ERMA New Zealand are listed in the ERMA New Zealand register, and published 11 times a year in their publication "The Bulletin". ERMA New Zealand's annual report also summarises the numbers and types of applications and decisions it makes each year. For publicly notified applications, submitters are notified of the decision.

You can also register on register on ERMA New Zealand's website to receive e-mails advising you of new regulatory information and decisions.

What if I don’t agree with a decision?

Approvals can only be challenged in court on points of law (that is, how the decision was made) not over whether someone considers that the decision reached is wrong. This means that a decision can only be challenged if it can be demonstrated that the decision-making process did not follow the procedures set out in the HSNO Act or the decision-making methodology.

Compliance costs for approval users

Containment facilities (including outdoor containment facilities such as field test sites) require monitoring by MAF Biosecurity New Zealand. The costs will depend on the type of monitoring and whether remedial actions are required following an inspection. Contact Biosecurity New Zealand to find out about compliance charges.

Breaches of containment controls may result in compliance action, including fines, either under the HSNO Act or the Biosecurity Act (or other relevant legislation).

Hazardous substances

The Regulatory Wayfinder currently focuses more on new organisms than hazardous substances, so questions about hazardous substances should be directed to ERMA New Zealand. However, to briefly summarise, the application types for hazardous substances are:

More information is available on ERMA New Zealand's hazardous substances web pages.

If a hazardous substance is also a new organism (for example a fungus used as a pesticide) then approvals under both the hazardous substances and new organisms parts of the HSNO Act may be necessary.

What other regulatory approvals may be required?

In addition to HSNO Act approvals, other approvals may also be required before the research or activity can proceed. Other regulatory requirements may include, although not be limited to the list below.

MAF Import Permit

If the new organism is to be imported, an import permit (Permit to Import) is usually required from MAF BNZ. Under most circumstances an import permit cannot be issued by MAF BNZ if a MAF import health standard (IHS) does not already exist for that type of organism. If a relevant IHS exists you need to ensure that the new organism(s) you wish to import are on a Permit to Import that has been issued to your organisation. This needs to be done before the new organisms are sent.

Information on IHSs is available on Biosecurity New Zealand's website. For example, there is an import health standard for the Importation into New Zealand of Animals for Laboratory Purposes from All Countries.

The packaging and labeling requirements for imported new organisms can be found in the relevant HSNO Act import approval and the appropriate MAF-ERMA Containment Standard.

Export of Living Modified Organisms

Exports of living modified organisms are regulated under the Imports and Exports (Living Modified Organisms) Prohibition Order 2005. LMOs include GMOs, as well as organisms resulting from fusion of cells from species in different taxonomic families (such as producing a new crop type by fusing cells from a grass species and cells from a carrot, or creation of hybridomas for the production of monoclonal antibodies). The MfE's website outlines the requirements that must be fulfilled by exporters of LMOs.

Animal Ethics Approval

If the research and development involves animals an approval from an accredited animal ethics committee will probably also required. See the Animal welfare section of the Regulatory Wayfinder.

Human Ethics Approval

If the research and development involves use of human cells or tissues (such as taking a blood sample and extracting the DNA) an approval from an accredited human ethics committee is also required. See the Human ethics section of this site. If human cells are being sourced from an international or national culture collection then human ethics approval may not be necessary. Talk to your human ethics committee about this.

Medicines Approval

If the new organism is to be used as part of a medicine, approvals from Medsafe and the Director-General of Health are required before the medicine can be marketed in New Zealand. See the Medicines section of the Regulatory Wayfinder.

ACVM Approval

If the new organism or hazardous substance is used as part of an agricultural compound or veterinary medicine then approval from the NZFSA is also required before the compound or medicine can be marketed in New Zealand. See the Animal medicines section of the Regulatory Wayfinder.

Food Standards Approval

If the new organism is used as part of a food approval from the Ministerial Council, made up of the New Zealand and Australian Ministers of Food, is required before the food can be marketed in New Zealand. See the Food section of this site.

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