New Organisms (and Hazardous Substances)
How are genetically modified organisms regulated in New Zealand?
- What is regulated?
- What is not regulated?
- Why are new organisms and hazardous substances regulated?
- Regulatory Process
- Processing paths for new organisms
- Other approvals
- Time and Cost
How are hazardous substances and new organisms 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 (ERMA NZ), or another body which has received delegated decision making powers from the Authority (such as an Institutional Biological Safety Committee at a research institute). The Authority is the part of ERMA NZ that generally makes the decision on whether to approve or decline an application. More information on ERMA NZ and the Authority 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 Biosecurity New Zealand (formerly MAF Biosecurity), which is part 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 new 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 it develops that 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 NZ website.
What is regulated?
Hazardous substances
A new hazardous substance is one that was not legally existing in New Zealand before 2 July 2001 and one that triggers the HSNO hazardous property thresholds defined in the Hazardous Substances (Minimum Degrees of Hazard) Regulations. ERMA NZ has produced Guidance information on these thresholds, and an information sheet on whether an approval is needed [4 pages, 437Kb, PDF].
"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 whether your research is exempt with ERMA NZ. An information sheet on exemptions for small-scale use [6 pages, 440Kb, PDF] is also available. Originally these exemptions did not apply if the substance was sold, but proposed amendments to the HSNO Act being considered by Parliament in 2005 may result in modification of this restriction. Check with ERMA NZ for the current situation and requirements.
If you are not sure if a particular substance is a new hazardous substance look at information on ERMA's website and/or contact ERMA NZ. You can apply to ERMA for a formal determination as to whether or not a substance is hazardous. Contact ERMA NZ for more information on this.
New organisms
Organisms that were not present in New Zealand immediately before the Hazardous Substances and New Organisms ("HSNO") Act 1996 came into effect (in July 1998) are considered "new" and require an approval to be imported, developed, 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 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 this is also regulated. For example, an approval will be probably be required to breed two different strains of GM mice.
For those interested in biotechnology GMOs are likely to be of most interest, but some non-modified organisms used for fermentation or other application may also require approval if they are new to New Zealand.
Living modified organisms (LMOs) are regulated at the import and export level under the Cartagena Protocol on Biosafety, which New Zealand has ratified. LMOs include GMOs, but also include some types of organisms that are not regulated by the HSNO Act - these are 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 sepcies and cells from a carrot, or creation of hybridomas for the production of monoclonal antibodies). See the Other Approvals section below for information on regulatory requirements.
If you are not sure if a particular organism is new, a GMO, or a LMO contact the Environmental Risk Management Authority of New Zealand (ERMA NZ). If you have evidence that an organism is not new you can make an application to ERMA NZ to determine whether the organism is new or not.
Prohibited organisms
Some organisms are prohibited from being introduced into New Zealand. These organisms are listed in Schedule 2 of the HSNO Act, and include any snake, as well as a variety of other venomous, dangerous or pest plants and animals.
What is not regulated?
Hazardous substances
Many substances will not be 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 [58 pages, 472Kb, PDF]. In addition, or alternatively, the substance may be an existing hazardous substance convered by transitional provisions of the HSNO Act. Contact ERMA NZ for more information.
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 NZ for more information on these.
New organisms
Once a new organism has been approved for unconditional or full release in New Zealand it is no longer considered "new" and becomes unregulated.
Genetic modification of human beings is not regulated by the HSNO Act. This is regulated under the Medicines Act 1981, and more information can be found in the Medicines section of this website. However genetic modification of cells or tissues derived from humans is regulated by 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.
Cloned animals are also not considered genetically modified or new organisms (if they are derived from species already in New Zealand), and so are not regulated under the HSNO Act. Their development may, however, require approval from an animal ethics committee.
More information on what is not considered genetic modification can be found in the HSNO (Organisms Not Genetically Modified) Regulations 1998.
Plants, animals or micro-organisms that come to New Zealand using their own abilities (such as by flying, floating, or hitchhiking on something else) are not regulated by the HSNO Act. However, 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.
Why are new organisms and hazardous substances regulated?
A range of species introduced into New Zealand previously (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 HSNO Act 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.
Regulatory Process
Hazardous substances
The Regulatory Wayfinder currently focuses more on new organisms than hazardous substances, so questions about hazardous substances should be directed to ERMA NZ. However, some of the information on the processing of new organisms applications given below may provide helpful information for those interested in how hazardous substances are considered. Application types for hazardous substances are:
- Determining a Status of a Substance.
- Importation or Manufacture of a Hazardous Substance for Release (rapid assessment)
- Importation or Manufacture of a Hazardous Substance for Release
- Importation or Manufacture of a Hazardous Substance in Containment
- Transhipment of a Hazardous Substance
- Emergency Release of a Hazardous Substance
- Reassessment of a Hazardous Substance
More information is available on ERMA NZ'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. Talk to ERMA NZ about this.
New Organisms
A quick guide to the regulatory process for new organisms [6 pages, 531Kb, PDF] is available from ERMA NZ. In 2003 significant changes were made to the new organisms part of the HSNO Act. These made some application processes easier (such as imports of genetically modified organisms, and covering projects rather than individual organisms for low risk GMO research), and also introduced a new application category (called conditional release). Some of these changes are included below. If you have not made an application to ERMA or an Institutional Biological Safety Committee recently, then check with them because requirements may have changed.
The basic processing path is as follows:
- An application is made on an approved form. This identifies, among other things, the organism(s) and nature of the genetic modifications, why the new organism is required, anticipated effect(s) of the new organism and genetic modifications, any risks to human health or the environment, and steps (and effectiveness of them) taken to manage those risks.
- A decision making committee assesses the application and any other relevant information associated with it.
- A decision is made. Usually there will be conditions or controls associated with an application that is approved.
The regulatory process depends on the type of new organism and the purpose for which it is required. The more significant or complex an application is the more information will need to be provided and the longer the assessment process will be. Applications are required for:
- Determination of whether or not an organism is a new organism
- Transhipment of a new organism
- Import into containment of a new organism
- Development in containment of a new organism
- Field test of a new organism
- Conditional release of a new organism
- Full release of a new organism
Most applications come with user guides to help fill out the forms. See the publication page on ERMA NZ's website for these and other information sources.
Determination on whether something is a new organism is for organisms that are believed to be present in New Zealand before the commencement of the HSNO Act but their presence is not recorded in a statutory database (such as ERMA's organism register or MAF's Plants Biosecurity Index). More information on determining whether an organism is new or not is available on ERMA NZ's website and in a quick guide to applying for new organism approval [6 pages, 531Kb, PDF] produced by ERMA NZ. At the time of writing there was no charge for a statutory determination but a fee may be charged for a determination from August 2005 - check with ERMA NZ.
Transhipment of a new organism is where the organism is imported into New Zealand but is destined to 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. Controls on where and how the organism can be kept can be placed on such shipments. Talk to ERMA NZ if you require a transhipment approval. The Application fee at time of writing was $1000.
Imports 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 are brought in to be released (such as a new plant species for gardens). For imports of "low risk" GMOs you can apply to import a group of GMOs that are to be used for the same project in the same application. The relevant ERMA user guides are:
- Making an application to Import into Containment any New Organism that is Genetically Modified [31 pages, 123Kb, PDF]
- Making an application for Rapid Assessment to Import into Containment Low-Risk Genetically Modified Organisms [32 pages, 106Kb, PDF]
- Making an application to Import into Containment any New Organism that is not Genetically Modified [26 pages, 101Kb, PDF]
In addition to an approval from ERMA, imports of new organisms will also require a MAF Import Permit. See the section on MAF Import Permits below.
Note that import approvals issued by ERMA may be able to be used by others to import the same organisms if they can meet the approval controls. You can check ERMA's register to see what approvals have been given and the controls applied. Import approvals issued by IBSCs (see below) are not able to be used by other organisations.
You may also be able to request transfer of a specific new organism from the original importer instead of importing the organism yourself. This will require a transfer permit from Biosecurity New Zealand. Talk to ERMA NZ if you want to find out more about transferring new organisms within New Zealand.
Developments are where a GMO is created, or a new organism is regenerated (eg through cloning) in New Zealand, in a registered containment facility. Large scale fermentation or liquid culture of a new micro-organism is now also considered a development. 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. The relevant ERMA user guides are:
- Making an application for Rapid Assessment to Develop in Containment a Project of Low-Risk Genetically Modified Organisms [38 pages, 456 Kb, PDF]
- Making an Application to develop within a Containment Structure any Genetically Modified Organism (other than by Rapid Assessment) [41 pages, 457Kb, PDF]
- Making an application for approval to Develop in Containment outside of a containment structure any Genetically Modified Organism [30 pages, 387Kb, PDF]
A field test is distinct from a development in that a field test is to "evaluate the new organism under conditions similar to those of the environment into which the organism is likely to be released", whereas a development is concerned with creation of a GMO and not necessarily investigating its performance or behaviour outside of the laboratory. This distinction is not always straightforward, so you may need to discuss with ERMA NZ how certain research should be classified and what type of application is appropriate. Note that Field Tests are considered to be contained use of new organisms. Field test approvals cannot be given for research involving plants that will release pollen or seeds into the environment. Such trials need to seek a conditional release approval. The relevant ERMA user guide is Making an application to Field Test in Containment any Genetically Modified Organism [20 pages, 317Kb, PDF].
A release is one 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). A release may result in the organism freely spreading, reproducing, and establishing a self-sustaining population in New Zealand, but some new organisms (such as some crops or ornamental plants) may not be able to persist without human assistance.
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.
A full release is where no conditions are made on the approval - the organisms can be grown or released as desired. Such an organism is then no longer a new organism. A conditional release is where certain requirements are imposed. 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. Relevant available ERMA user guides are:
- Making an application to Import for Release or Release from Containment with controls any New Organism [33 pages, 359Kb, PDF]
- User Guide To Making An Application for approval for the release of a qualifying organism by rapid assessment Under The HSNO Act 1996 [37 pages, 353Kb, PDF]
Check ERMA's new organisms publication page on its website for other user guides. If you are interested in releasing a new organism in New Zealand you should talk with ERMA NZ to help determine what type of release application is appropriate.
What if a new organism is required for an emergency?
There are provisions in the HSNO Act for applications to be made to release a new organism in an emergency (section 47 of the HSNO Act) or for rapid assessment and release of agricultural compounds and medicines in a special emergency (section 49D of the HSNO Act). An "emergency" is defined in section 46 of the HSNO Act, and a "special emergency" is defined in section 49B of the HSNO Act.
In such cases a new organism can be released to prevent or reduce risks to humans, valued species or the environment caused by incidents such as an infectious disease, oil spill or other environmental calamity. The new organism must be necessary to be able to deal with the emergency or special emergency. Such applications are rapidly assessed and there is no public consultation. For more information on use of new organisms in emergencies and special emergencies contact ERMA NZ. At the time of writing the application fee for release of a new organism in an emergency was $10,000.
Involving Māori in the process
An important aspect of the HSNO Act is the requirement to discuss certain types of application with Māori before they are submitted to ERMA NZ. If genetic material from humans or native or valued flora and fauna are involved with GMO developments, field tests or releases, or native species or cells derived from Māori individuals are modified, then relevant Māori groups will need to be consulted before making an application. Consultation does not necessarily mean obtaining the support of those groups, but applicants need to demonstrate that they have discussed their work with relevant Māori, listened to concerns, and attempted to address those concerns. ERMA NZ has information on taking account of Māori perspectives and a user guide on working with Māori [25 pages, 419Kb, PDF], or you can talk with ERMA NZ.
Consultation procedures under the HSNO Act process continue to evolve, so check with ERMA NZ for the latest guidance.
Processing paths for new organisms
Rapid assessments
Regulatory process
Making a submission on a notified application
How can I find out about decisions?
Making minor changes to ERMA approvals without making a new application
What if I think a decision is wrong?
Reassessment of approvals
There are three main processing paths for applications:
- Notified application - This is for field testing or release of new organisms, or for any other type of application where the Authority considers there may be significant public interest. Such applications will usually be publicly notified, and the public and interested groups can make written submissions saying why they support or oppose the application, or indicate factors that should be taken into account before a decision is made. A public hearing may also be held so that the decision-making committee of the Authority is able to more fully hear and consider issues associated with the application.
- Non-notified application - This is for most applications to import or develop new organisms in containment. ERMA NZ may request comments on the application from specific agencies (such as MAF or the Department of Conservation) or organisations, or from other technical experts, but the application is not publicly notified.
- Rapid assessment application - In certain cases applications for import or for development in containment may meet low risk criteria and be eligible for more rapid (40 day) processing than standard non-notified applications.
Rapid assessments
Rapid assessment applications are available where applications involve new organisms that meet specified "low risk" requirements. "Low risk" means that the organisms are unlikely to cause adverse effects on humans or the environment. The use of the term "low risk" does not mean that other types of new organisms are "high risk". Any approval for a new organism must have identified, assessed and managed potential risks to ensure that the residual risk to people and the environment is low.
The rapid assessment route is available for:
- certain human medicines and veterinary medicines that are or contain new organisms and pose little risk to humans and the environment. To determine if a human medicine or veterinary medicine is considered able to undergo an ERMA rapid assessment talk to ERMA NZ, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) or the Agricultural Compounds and Veterinary Medicines (ACVM) Group of the New Zealand Food Safety Authority (NZFSA). ERMA New Zealand also has an information sheet [2 pages, 49Kb, PDF] available.
imports or developments of GMOs that are considered low risk. These low risk requirements are specified in the HSNO (Low Risk Genetic Modification) Regulations, and the GMOs must be kept in an appropriate registered containment laboratory. Generally low risk GMOs are organisms that are unlikely to escape and survive outside of the laboratory, and are unlikely to infect or harm humans, animals or plants that they come in contact with. Examples of low risk GMOs are non-pathogenic laboratory strains of bacteria that contain "gene libraries" from other species, and genetically modified laboratory mice used in medical research.
For more information about low risk GMOs read ERMA NZ's "Interpretations and Explanations of Key Concepts", and the user guide "Making an application for Rapid Assessment to Develop in Containment a Project of Low-Risk Genetically Modified Organisms" (both available on ERMA NZ's website), or talk to ERMA NZ.
- release of non-GMOs that are considered low risk (such as some non-weedy and non-toxic garden plants). The criteria for such organisms being considered low-risk are given in section 35 of the HSNO Act, or you can talk to ERMA NZ.
Decisions on rapid assessment applications may be able to be delegated to someone other than ERMA NZ. For example, 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. IBSCs are regularly audited by ERMA NZ to ensure that applications submitted to them and the decision making process are consistent with the HSNO requirements.
Where an institute does not have an IBSC, ERMA NZ will do the assessment and decision-making.
Regulatory process
In all types of applications the regulatory process involves the following steps:
- An applicant completes an application form that describes the new organism and its biology, why it is required, and identifies and assesses risks associated with the organism, along with steps to manage such risks.
- ERMA NZ or an IBSC assesses the application for information content and adequacy of the risk assessment. It may request further information or assessment from the applicant, or others (such as other government agencies, or researchers). To assist the Authority in its consideration of the application ERMA NZ produces an evaluation and review report that assesses the information provided in the application.
- The IBSC or a decision-making committee of the Authority considers the application and any other information it deems relevant before making a written decision. (With applications made to ERMA NZ additional information can include the ERMA NZ evaluation and review report, a report from Ng? Kaihaut? Tikanga Taiao, public submissions (if a notified application), comments from other government agencies, or additional technical advice). The decision may decline the application or approve it with (in most cases) or without (if a full release) controls. An approval with controls may specify a time limit on the approval, as well as a broad range of other controls.
An application may be declined for various reasons. For example, the risks may exceed the benefits, or there may be insufficient information to fully assess the application. Under section 140(h) of the HSNO Act the Authority can declare that a declined new organism (or any new organism) be listed as a risk species if it poses unacceptable risks, so that it is not allowed to be introduced into the country.
Making a submission on a notified application
Advertisements calling for public submissions on notified applications are placed in the public notices section of major newspapers, and other methods may also be used. Alternatively, you can register your areas of interest with ERMA New Zealand and they will alert you when notified applications of that type are open for submissions.
Details of notified applications are posted on ERMA's website. You should read at least the application summary before making a submission. Submissions are a valuable means of contributing to decision-making through raising issues, providing information and contributing perspectives. It is the content of a submission that is important, rather than the number of submissions lodged. Repetitive submissions each saying the same thing do not add value to the decision-making.
Submissions need to be made within 30 days of the application being publicly notified. Submissions must be in writing and should include any decision sought, the reasons for it, and whether you are requesting a hearing. Submitters will need to cover their own costs for attending a hearing.
How can I find out about decisions?
All decisions made by ERMA NZ are listed in the ERMA NZ register, and published 11 times a year in their publication "The Bulletin". ERMA NZ's annual report also summarises the numbers and types of applications and decisions it makes each year. For publicly notified applications, those who appeared at the hearing will be notified of the decision. See ERMA's website for more information.
You can also register on ERMA's website to receive e-mails advising you of new regulatory information and decisions.
Making minor changes to ERMA approvals without making a new application
For already approved applications it is possible for researchers to request amendments (via section 67A of the HSNO Act) to approvals if these are considered minor or technical amendments. Such amendments can be rapidly made (by the IBSC or ERMA NZ) if they do not alter the level of risk, or significantly change the nature or scope of the approved activity. 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. Talk to ERMA NZ if you want to know whether an existing approval can be amended. The relevant ERMA application form is "Proposal for amendment to an IBSC decision under section 67A of HSNO Act (1996) [Word document, 32kb].
In early 2005 there was no fee to request minor or technical amendments, but this may change in August 2005. Check with ERMA NZ.
What if I think a decision is wrong?
Authority decisions 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 Authority's decision-making methodology.
If after a decision is made and new relevant information becomes available, or if someone considers that relevant information was not considered during the decision-making phase, then a request can be made to ERMA NZ to reassess the application.
Reassessment of approvals
Anyone may request that the Authority consider whether there are grounds for reassessing an approval for a new organism in containment or a conditionally released or qualifying organism. The Authority may decide that there are grounds to reassess a new organism if significant new information relating to the effects of the organism has become available. If there are grounds for reassessment then the reassessment is treated as a new application. More information on reassessing applications can be obtained from ERMA NZ. In early 2005 there was no application charge for a "Determination on grounds for reassessment", but a charge may be imposed later in 2005. Check with ERMA NZ.
A reassessment may result in the original approval being declined, changes being made to controls and conditions on the original approval, or no change being made to the original approval. The relevant ERMA application form is Grounds for Reassessment of a new organism in Containment [5 pages, 208Kb, PDF].
Other approvals
In addition to an ERMA approval, other approvals may also be required before the research or activity can proceed.
MAF Import Permit
If the new organism is to be imported an import permit (Permit to Import) is usually required from MAF. Under most circumstances an import permit cannot be issued by MAF 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, otherwise you will need to get the new organisms added to an existing permit or get a new Permit to Import from MAF. This needs to be done before the new organisms are sent.
Information on IHSs is available on Biosecurity New Zealand's website. Note that MAF IHS's can take several months to develop and may cost more than some ERMA approvals, so prospective applicants should check with Biosecurity New Zealand whether an appropriate IHS exists before applying for an import approval.
The Biosecurity New Zealand website lists current animal import health standards, and current plant and microbial import health standards. For example, there is an import health standard for the Importation into New Zealand of Animals for Laboratory Purposes from All Countries and also information on how to apply for a permit to import micro-organisms and microbiological samples.
Those importing new organisms should ensure that the importation documents include the permit and a reference to the ERMA approval number. The importer must ensure that the identity of the organism can be readily established against the import documentation by the MAF Quarantine Service (MQS) staff when they inspect. Special storage conditions should be obvious to the Inspector in accompanying documents, as should be any special handling conditions related to the inspection (eg the use of protective equipment). Any ERMA controls related to transport (eg use of IATA containers) must be clearly visible to the MQS Inspector.
Please make sure that this information is readily available - it will expedite the importation process.
Export of Living Modified Organisms
Exports of living modified organisms will usually require consent from the Minister for the Environment. Note that the definition of living modified organisms is broader than the HSNO definition of GMOs. For instance, it includes human-mouse cell fusions (and similar types of hybridomas) used in the laboratory production of monoclonal antibodies, and cell fusions between members of different plant families.
Consent for export will not be required if the LMO is a pharmaceutical for humans and is covered by relevant international agreements or organisations other than the Cartagena Protocol on Biosafety. Otherwise LMOs intended for contained use, direct use as food or animal feed, or for processing, or for intentional release into the environment will require consent.
Consents will be given if handling, packaging and transport meet relevant international rules and standards, the appropriate documentation accompanies the LMO, other export requirements are met, and requirements of Article 11 of the Cartagena Protocol on Biosafety are complied with if the importing country is a party to the Protocol.
In general this process will involve exporters informing ERMA New Zealand (who is a designated Competent National Authority for the Biosafety Protocol) before they wish to export. ERMA New Zealand will check that the requirements have been met and if so they will inform the Biosafety Clearing House, issue an export approval reference and the LMO can be exported. More information on requirements for exporting LMOs is available on MfE's website. ERMA NZ will also be providing additional information on their website. For more information about this process talk with ERMA New Zealand.
The Imports and Exports (Living Modified Organisms) Prohibition Order 2005 is the relevant regulation covering export of LMOs.
Animal Ethics Approval
If the research and development involves vertebrate 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. Note that if human cells are being sourced from an international or national culture collection then human ethics approval may not be necessary. Talk to ERMA NZ or your human ethics committee about this. Genetic modification of human beings (rather than human cells in the lab) is regulated by the Ministry of Health not ERMA. See the Human medicines and Human ethics sections of the Regulatory Wayfinder.
Medicines Approval
If the new organism is 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 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.
Time and Cost
Time and costs associated with applications depends on the application type. Discussing complex applications with ERMA NZ before submitting an application, and including all relevant information in an application will help keep processing time and costs down. See ERMA NZ's "What will it cost?" information sheet for current application costs. Note that some ERMA application fees may change in August 2005, so that some of the costs indicated below may not be current. Processing times could also change in the future so please check with ERMA NZ or other relevant agencies for current pricing and processing times.
Notified applications are expected to be processed within 100 working days. However, if further information is required or the issues are particularly complex the process can take longer. There are fixed fees for most application types, except conditional release and full release of GMOs. An application to field test a GMO will incur an application processing charge of $35,000.
Non-notified applications are expected to be processed within 60 working days, and will cost in the order of $1000. (Note that the cost for a non-notified application may increase in August 2005)
Rapid assessments should be processed within 40 working days. If done through ERMA NZ such assessments will cost as little as $500, but there may be no direct charge if submitted through an IBSC.
Costs associated with other types of HSNO applications are noted in earlier sections of this page.
Compliance Costs
In addition to approvals from ERMA, an updated or new import permit may be required from MAF to meet the requirements of the Biosecurity Act for the importation of a new organism. Currently adding a new item to an existing permit costs $60 and issuing a new permit costs $180.
IBSCs with delegated authority from ERMA must pay a one off fee to register their delegation and must also pay ERMA NZ auditing costs. More information on these charges can be obtained from ERMA NZ.
IBSCs must also make sure that they consider the time and cost associated with the importation process and the management of risk as a result of the transport process when new organisms are imported into New Zealand.
Containment facilities and field tests will also require monitoring by MAF Quarantine Service. These monitoring costs will often be charges to the institution rather than to the researcher. 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 conditions or ERMA approvals may result in compliance action, including fines, either under the HSNO Act or the Biosecurity Act (or other relevant legislation).

