Frequently Asked Questions (FAQ)
Where can I find out more about biotechnology in general, not just about the regulatory side?
What regulations are there for protecting the environment?
What are the regulations covering Bioprospecting?
How do I know if an organism is "new"?
If I have an approval to develop a GMO or other new organism can I also import it, or vice versa?
Do I need an approval to breed from a GMO?
Can I make a minor change to an ERMA approval without making a new application?
Does a new organism need a containment approval before it can be released?
What is the difference between the HSNO Act and the Resource Management Act?
What is the difference between the HSNO Act and the Biosecurity Act?
What is the difference between genetic modification and genetic engineering?
How can I find out if something is genetically modified?
How do I get to comment on GM issues?
What do I need to get approval to grow a GM plant in New Zealand?
What things are regulated as medicines in New Zealand?
Are medical devices regulated?
Pharmac - what is it and how is it involved in Biotechnology?
How many animals are required for a clinical trial?
Am I allowed to clone myself or my cat?
What are the regulations covering the creation, collection or use of human stem cells?
How is food regulated in New Zealand?
What GM foods are sold in New Zealand?
How are GM foods for animals regulated?
What is the time and cost involved in getting a medicine/new food/animal vaccine to market?
What's not regulated and why?
- Where can I find out more about biotechnology in general, not just about the regulatory side?
The New Zealand Biotechnology Learning hub provides information about biotechnology for students and teachers. MoRST's website also provides examples of the types of biotechnology undertaken in New Zealand, and future trends in biotechnology. Other information on biotechnology companies is availabe on NZBio's website.
- What regulations are there for protecting the environment?
There are a range of regulations. The Regulatory Wayfinder covers regulation of "new organisms". You can visit the Ministry of the Environment website to find out about some other environmental regulation, such as the Resource Management Act, and National environmental standards. Biosecurity New Zealand is responsible for the Biosecurity Act, and the Department of Conservation is responsible for the Conservation Act. The Parliamentary Commissioner for the Environment also produces reports that may draw attention to issues associated with aspects of environmental regulation.
- What are the regulations covering Bioprospecting?
Bioprospecting involves the study of micro-organisms, plants, animals and other biological resources for properties that may be of value for commercial development (such as cosmetics, new materials and medicines).
The Ministry of Economic Development is responsible for developing a policy framework for regulating bioprospecting activities in New Zealand. This involves developing conditions to facilitate access to genetic resources as well as measures to achieve fair and equitable benefit-sharing from the utilisation of genetic resources. Their website has more information about bioprospecting policy in New Zealand and internationally.
- How do I know if an organism is "new"?
A new organism is one not present in the New Zealand environment before July 1998. If you are unsure whether an organism is new or not, contact ERMA NZ. If you consider that an organism is not new but it is currently considered new by ERMA NZ then you can make an application to determine whether an organism is new or not (often called a "section 26 application", since this refers to section 26 of the HSNO Act). This requires clearly identifying the organism and where it is normally found, along with information that may support it being in New Zealand before July 1998, or having subsequently arrived and established by its own abilities. Some organisms that are not new may be considered unwanted organisms (such as fire ants) and be subject to management under the Biosecurity Act 1993.
- If I have an approval to develop a GMO or other new organism can I also im?ort it, or vice versa?
No. Just because you have an approval to develop (or import) a particular type of new organism does not allow you to import (or develop) it under that approval. Developments and imports require separate approvals. See the New organisms section of the Regulatory Wayfinder.
- Do I need an approval to breed from a GMO?
If you are breeding GMOs of the same modification and strain together to maintain the GMO then no additional approval is necessary. Similarly, if you mate the GMO back to the parental unmodified strain from which the GMO was derived then an additional approval may not be necessary. However, if you intend to breed two different types of GMO to produce novel GMOs, or to cross a GMO with a different non-GM strain of the organism then a development approval will be required from ERMA NZ or an IBSC. Breeding of different strains can be included in the original application to develop the GMO, or could be done as an update to a devlopment application. If you are breeding from imported GMOs then an additional development approval will be necessary. See the New organisms section of the Regulatory Wayfinder for more information on applications. Talk to ERMA NZ for more information if you are uncertain about breeding from GMOs.
- Can I make a minor change to an ERMA approval without making a new application?
See the Making minor changes to ERMA approvals without making a new application section of the regulatory wayfinder for information.
- Does a new organism need a containment approval before it can be released?
Not always. It is possible to apply for a full release approval (or any other type of approval) without having already applied and received approval for the other types of application. However, for some new organisms a containment approval may be required before a release is made in order to test for some potential risks. For organisms that are not genetically modified it is possible to make a single application that covers both the import and release of a new organism. Talk to ERMA New Zealand if you are unsure what application(s) you need to make.
- What is the difference between the HSNO Act and the Resource Management Act?
The Resource Management Act (RMA) promotes the sustainable management of natural and physical resources. Its core purpose is to help achieve sustainability in New Zealand. The RMA requires local government to promote sustainable management of natural and physical resources. The HSNO Act provides the means to set conditions on the management of hazardous substances and new organisms which apply irrespective of location. Conditions to manage the risks at a particular site will continue to be set under the Resource Management Act through the resource consenting process.
Where a local authority imposes conditions under the Resource Management Act, such conditions may only add to the controls imposed under the HSNO Act - they cannot be less than the minimum requirements under the HSNO legislation. More information is avalable on the Ministry for the Environment's website.
- What is the difference between the HSNO Act and the Biosecurity Act?
The HSNO Act is concerned with the regulation of organisms that may be wanted in New Zealand, while the Biosecurity Act is concerned with the management of organisms that are not wanted in New Zealand. The purpose of the Biosecurity Act is to enable New Zealand to exclude, eradicate or effectively manage pests and unwanted organisms already in the country or to stop them from entering. The HSNO Act is designed so that the deliberate importation, development or release of new organisms into?New Zealand may be examined in advance to assess the effects on people and the environment.
More information on the Biosecurity Act is available from the Biosecurity New Zealand website.
- What is the difference between genetic modification and genetic engineering?
Nothing, these terms (often abbreviated to GM and GE) are frequently used interchangeably. Some people prefer using one term over the other. For example, some consider that GE better reflects human involvement in the process. This site uses the term genetic modification since that term is used in the Hazardous Substances and New Organisms Act.
- How can I find out if something is genetically modified?
Genetically modified organisms (GMOs) usually look the same as non-modified ones, so just because a plant or animal looks "different" or "mutated" does not mean that it has been genetically modified.
Any viable GMO that is released in New Zealand must have an approval from the Environmental Risk Management Authority of New Zealand (ERMA NZ). If you want to find out if a plant, animal or microbe is genetically modified contact the ERMA NZ.
To date (mid 2005) no GMOs have been approved for release outside of research facilities in New Zealand. However, some medicines, foods, food additives, industrial products and household enzymes available in New Zealand are derived from GMOs. For example, some medicines and industrial products are produced by GMOs but the products themselves (such as insulin or enzymes for washing powders) are not organisms. Some genetically modified (GM) foods are approved for sale in New Zealand. These are imported products that are not allowed to be grown here and must be imported as processed goods. They include products that are derived from GM crops (such as some canola oil, and some corn products).
If you want to check if a food or veterinary medicine contains GM products contact the New Zealand Food Safety Authority. If you want to find out if a medicine is derived from a GMO contact the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).
Some companies or laboratories can do tests to identify whether plants or foods contain certain GMOs, but there is no simple readily available test to identify all GMOs or products of GMOs.
Information on crops that are GM can be found on the AgBios website.
- How do I get to comment on GM issues?
The Environmental Risk Management Authority of New Zealand accepts public submissions on some types of applications involving genetic modification. See the New organisms section of the Regulatory Wayfinder.
Food Standards Australia New Zealand accepts public submissions when genetically modified foods are being considered for addition to the food standard. See the Food section of the Regulatory Wayfinder.
The Bioethics Council is undertaking a range of work on ethical aspects of biotechnology. From time to time they undertake public consultations. See their website for information.
- What do I need to get approval to grow a GM plant in New Zealand?
See the New organisms section of the Regulatory Wayfinder.
- What things are regulated as medicines in New Zealand?
See the Medicines section of the Regulatory Wayfinder.
- Are medical devices regulated?
Medical devices are required to be registered ?ith Medsafe. The regulation of medical devices is likely to change when New Zealand and Australia form a joint therapeutics agency in 2006. See the Medicines section of the Regulatory Wayfinder.
- Pharmac - what is it and how is it involved in biotechnology?
Pharmac is the Pharmaceutical Management Agency of New Zealand. It's role is to purchase on behalf of the Government pharmaceuticals that are approved for marketing in New Zealand, decide what pharmaceuticals will be subsidised, and to promote the responsible use of pharmaceuticals. Pharmac does not regulate the use of medicines, that is Medsafe's role.
- How many animals are required for a clinical trial?
Clinical trials are conducted on humans. Animals can be used in pre-clinical testing of a medical product or treatment. Contact Medsafe to discuss requirements for animal testing.
- Am I allowed to clone myself or my cat?
Cloning of humans is prohibited in New Zealand. See the Human ethics section of the Regulatory Wayfinder.
Cloning of animals is permitted, but will be subject to approval from an animal ethics committee. See the Animal welfare section of the Regulatory Wayfinder. Cloning by itself is not considered a genetic modification under New Zealand legislation, so cloned animals are not considered as genetically modified animals.
Home gardeners and plant nurseries often take cuttings and use grafting to naturally clone plant material. Most of New Zealand's plantation pine forests are derived from cloned material. Such cloning of plants does not require regulatory approval.
- What are the regulations covering the creation, collection or use of human stem cells?
The creation and use of embryos to produce embryonic stem cells is covered by the scope of the Human Assisted Reproductive Technology Act, but the subsequent use of embryonic stem cells and stem cell lines for research or therapy is not. The Ministry of Health is currently developing guidelines on the use of imported existing embryonic stem cell lines in research. It is anticipated that these guidelines will be completed by November 2005.
Use of adult stem cells is permitted and would be expected to require an assessment through a health and disabilities ethics committee. The current review of the Humans Tissues Act is expected to clarify requirements for the non-therapeutic use of tissues and cell lines, including stem cells. If clinical applications are involved then they will also require assessment by Medsafe. See the Human medicines section of the Regulatory Wayfinder. If stem cells are genetically modified, then an approval under the HSNO Act will be required. See the New organisms section of the Regulatory Wayfinder.
- How is food regulated in New Zealand?
See the Food section of the Regulatory Wayfinder.
- What GM foods are sold in New Zealand?
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It is difficult to know what GM foods are currently being sold in New Zealand without checking directly with food importers or suppliers. However, the Food Standard 1.5.2 [6 pages, 110Kb, PDF] of the Food Standards Australia New Zealand lists what genetically modified foods have been given pre-market clearance and could be sold in New Zealand.
- How are GM foods for animals regulated?
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Animal feed is regulated under the ACVM Regulations 2001, wh?ch require feed to be fit for purpose. "Fit for purpose" is defined as not causing the animal pain and distress from microbial, chemical or physical hazards. There is no explicit regulation of GM feed, although it would also need to be fit for purpose.
- What is the time and cost involved in getting a medicine/new food/animal vaccine to market?
See the relevant sections of the Regulatory Wayfinder.
- What's not regulated and why?
See the relevant sections of the Regulatory Wayfinder.
