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HSNO Amendment Act

Excerps from the government website about the hsno amendment act

Hon Marian Hobbs - Minister for the Environment

Government announces proposals for genetic modification regulation. The government has announced changes it wants to make to the main legislation covering genetic modification (GM) in the latest step in its programme to implement the recommendations of the Royal Commission on Genetic Modification.

The proposed changes are to the Hazardous Substances and New Organisms  (HSNO) Act 1996 and related Acts. They are designed to underpin the government's overall policy of proceeding with caution with GM while preserving opportunities.

"The decisions will give New Zealand an extended regulatory framework to allow it to better take advantage of the social and economic benefits of genetically-modified and other new organisms, which we may choose to use, while at the same time ensuring potential risks are managed effectively," Environment Minister, Marian Hobbs said.

The changes being proposed include a new category of approval for new organisms, including genetically-modified organisms, called 'conditional release'.

"This new category would ensure a regulatory framework is maintained for new organisms by allowing the Environmental Risk Management Authority (ERMA) to attach controls on a case-by-case basis to any approvals to release new organisms," Marian Hobbs said.

"It would allow the ERMA to consider applications to conduct certain research outside strict containment such as monitoring the impacts of released organisms. It would also allow ERMA to impose controls designed, for example, to prevent the dissemination of the organism into the wider environment. The conditional release category would also allow ERMA to specify where and how organisms are used. 

"This will not automatically mean that all new organisms will be approved for conditional release and it will certainly not mean that GM organisms will automatically be released.

"To back up the cautious approach inherent in this new category, measures are also being introduced to enforce the rules and provide for deterrent penalties against those who breach them."

Other proposed changes to the act would streamline the approval process for the import and development of low-risk genetically modified organisms in contained laboratory conditions. The system for medicines that contain new organisms would also be simplified for those meeting the criteria for 'low-risk', with those products needing only one approval rather than the 
two required at the moment.

There is also provision for a rapid approval system for products required urgently to deal with a human or animal health or biosecurity emergency.

Cultural, spiritual and ethical effects have also been added to the list of circumstances under which the Minister for the Environment may step in to decide on an application to develop or release a new organism or hazardous substance - a process known as Ministerial call-in.

Another set of amendments is designed to improve the way the Act operates for decision making on new organisms in the light of experience with the Act since 1998.

The law change proposals are the latest step in a series of government  decisions implementing the recommendations of the Royal Commission on Genetic Modification. 

These include the establishment of Toi te Taiao: The Bioethics Council, public funding for research into the environmental, economic and social implications of genetic modification, and setting up a review of the ERMA to ensure it has the expertise and resources it needs to make decisions on GM research, development and use. 

The government is also drawing up a comprehensive strategy setting out a vision and goals for biotechnology (including GM) in New Zealand. 

New category for release of new organisms The government is proposing a new category for the release of new organisms, including genetically-modified organisms (GMOs), into New

The new category is called "conditional release" and would be an intermediate stage between new organisms in fully contained conditions and organisms released without any conditions.

"Currently under the HSNO Act we have only containment of new organisms or general release with no conditions. The proposed new category of conditional release will allow New Zealand to implement the findings of the Royal Commission on Genetic Modification to proceed with caution while preserving opportunities," the Environment Minister Marian Hobbs said.

The new category of conditional release would allow the Environmental Risk Management Authority (ERMA) to approve the release of new organisms, but only under certain conditions.

"The Royal Commission recognised that the current system failed to allow conditional release, " Marian Hobbs said.

As an example of the conditions that could be imposed, an applicant might want to grow GM carrots that when processed into possum bait produce infertility in possums. ERMA could impose controls restricting the location and size of the crop, and order that the carrots must not be allowed to flower so that there was no chance of the GM carrot pollen being carried to a non-GM carrot crop. This would allow applicants to grow the GM carrots to help reduce the possum population, while ensuring that they did not enter the human food supply.

In considering a new organism for conditional release, ERMA would need to look at it in the context of a set of minimum standards designed to protect our environmental health and biodiversity.

"The range of uses is far wider than just GM crops and the controls are not just to do with containment," the minister said.

"For example, in the case of a live GM vaccine such as some cholera vaccines, the controls could be that it be administered only under medical guidance and not to people with suppressed immune systems." 

ERMA would also have the power to review its conditional release approvals where new information or new technologies justified a change in the conditions of that approval.

The Minister says the framework for conditional release requires an effective enforcement regime and that role will be carried out by the Ministry of Agriculture and Forestry (MAF). The Ministry will be assigned new funding to allow it to carry out its new role and estimates are being done now of the funding required. 

"An enormous amount of work has gone into thinking through the framework for conditional release and I am very pleased with the outcome," Marian Hobbs said. 

Conditional release - how it would work The new category of conditional release being proposed by the government would allow the Environmental Risk Management Authority (ERMA) to impose conditions on the release of new organisms, including genetically modified organisms.

At the moment the HSNO Act authorises ERMA only to approve the full containment of new organisms, or full release of new organisms without any conditions. The Royal Commission on Genetic Modification recommended that the HSNO Act be amended to provide for a new category of approval called "conditional release", acknowledging that there was a gap in the law as it currently stands.

It likened the new category of conditional release to clinical trials that have been part of medical research for decades because it provides the opportunity to gather information about a new organism in a controlled way before approving it for full release. 

Creating a new category of conditional release would allow applications to ERMA for either the conditional release of a new organism, in which the applicant will propose conditions, or for applications for the general release of a new organism (release without conditions). When assessing an application for conditional release, ERMA will have the ability to impose stricter conditions than those proposed in the application. Similarly, when an application is made for general release, ERMA will have the ability to impose conditions and approve the application as a conditional release rather than a general release.

Some examples of conditions ERMA could impose under the conditional release category include that only one sex of an organism be released, a limit on the number of organisms released, or the auditing of the environmental or health impacts of the new organism. However, this is not a complete list. The government is proposing that ERMA's ability to impose conditions be broad, but that some matters ERMA may consider when imposing conditions will be listed in the HSNO Act to provide guidance to both ERMA and those submitting applications to ERMA.

Under the government's proposal for conditional release, ERMA will approve an organism for conditional release using essentially the same procedures for decision-making as are already available in the Act, including the comprehensive public process. Once an organism is released with conditions, it will remain a "new organism" and continue to be subject to the HSNO Act. This means that the existing machinery for checking compliance with conditions (currently set for new organisms in containment) and taking enforcement action can be used when needed, and the ability to reassess the organism is available.

While the Government is proposing that conditional release be an intermediate category between fully contained conditions and release without conditions, it will not be a compulsory stage between containment and release without conditions. In other words, there will be no particular sequence for approvals under the Act. But an organism cannot "swap" categories of release without first being reassessed by ERMA. If a new organism is released with conditions, for example, it will have to undergo a full reassessment by ERMA before it can be released without conditions.

Before considering an organism for conditional release, ERMA must consider whether the new organism could be recovered or eradicated if desired, and must take into account conditions and their likely effectiveness when determining whether the minimum standards currently set out in the Act are met. These minimum standards include the likelihood of the organism significantly affecting natural habitats or displacing native species within them, significantly altering New Zealand's genetic diversity, or causing disease or becoming a vector for human, animal or plant diseases. If the minimum standards are not met, ERMA cannot approve the conditional release of the new organism.

Examples of uses and controls Conditional release could be applied in a wide range of circumstances and the associated conditions could also vary widely.

An applicant might want to grow GM carrots that when processed into possum bait produce infertility in possums. ERMA could impose controls restricting the location and size of the crop, and order that the carrots must not be allowed to flower so that there was no chance of the GM carrot pollen being carried to a non-GM carrot crop. This would allow applicants to grow the GM carrots to help reduce the possum population, while ensuring that they did not enter the human food supply.

It could also be used to better understand the action of biological control agents. Laboratory research can test many features of an insect, for example, that could be used to contain a pest plant or animals in New Zealand. However, conditional release would allow monitoring of the organism for effectiveness.

Conditions that could be applied include:
that only one sex of an organism be released (to prevent breeding) a limit on the number of released organisms a limit on where the organism can be released restricting how the organism is grown, raised or used (for example, making sure a plant does not flower) granting approval to a single user only, or only to users with particular knowledge, management systems, etc. limiting the purposes for which the organism might be used ensuring suitable disposal of a new organism at the end of research. Enforcement To work, conditional release needs to have a system of enforcement to ensure the controls imposed by ERMA when it grants approval are being carried out. 

That role would be undertaken by the Ministry of Agriculture and Forestry (MAF) under the direction of the Minister of Biosecurity. The Ministry already has an inspection and enforcement role. MAF Biosecurity is responsible for protecting New Zealand from unwanted pests and harmful organisms under the Biosecurity Act and for managing risks to plant and animal health and animal welfare. MAF inspectors also at present inspect laboratories doing GM work to ensure they are secure and have the proper approvals. MAF's other duties include guaranteeing the quality and hygiene standards of our exports and ensuring animals are treated humanely. The Ministry would receive extra funding to cover its new responsibilities under an amended HSNO Act.

Minister's call-in powers extended The government is proposing to add cultural, spiritual or ethical effects to the list of grounds under which the Minister for the Environment could
step in to decide on an application for the introduction of a new hazardous substance or new organism that had been made to the Environmental Risk Management Authority (ERMA).  

The proposed change is part of a series of amendments the government is proposing to the Hazardous Substances and New Organisms (HSNO) Act 1996 in the latest step in its implementation of the recommendations of the Royal Commission on Genetic Modification.

Under the ministerial call-in provisions of the Act, the minister can already step in in cases where there could be significant economic, environmental, international, and health effects as well as in cases where it is judged that ERMA lacks sufficient knowledge or experience to decide the case.

The proposal is to add significant cultural, spiritual and ethical effects to that list.

"This is a measure that the government takes extremely seriously," the Environment Minister Marian Hobbs said. "Exercising Ministerial Call-in would be a decision taken at the highest level and with considerable thought and care.

"Ministerial Call-in allows the minister to appoint people with relevant knowledge or experience to sit with ERMA to consider the particular application. The Authority conducts a public inquiry before reporting its recommendations to the minister. The minister then has 20 days to make a decision."

The government has already set up a special body, Toi te Taiao: The Bioethics Council, to advise it on the significant cultural, spiritual and ethical issues as they arise in the area of biotechnology (including genetic modification) and to promote public debate on these. The council will not advise on specific projects, but will concentrate more broadly on the issues in  current and future biotechnology research and development as they arise and their advice will be informed by public debate at a national level. 

"The government is aware that many people who made submissions during the public consultation on these changes wanted much more emphasis put on cultural, spiritual and ethical impacts of the new biologically-based technologies," Marian Hobbs said. "This amendment and the work of the Bioethics Council in anticipating where these issues will arise are
designed to do just that.

"The council was never set up to decide applications on a case-by-case basis. It would be an impossible and confusing situation if more than one body were to become involved with individual applications to develop or release new organisms. The ERMA already has the legal power to consider cultural issues in deciding on applications."

Strict civil liability and a civil penalties regime included in changes Government proposals for changes to legislation governing new organisms (including genetically modified organisms) include amendments to the HSNO Act to impose both a strict civil liability and civil penalties regime in cases where an activity breaches the law, Environment Minister Marian Hobbs said.

The strict civil liability amendments would cover cases where, for example, the necessary Environmental Risk Management Authority (ERMA) approvals had not been obtained or where conditions imposed by ERMA as part of approval had deliberately not been complied with. In these cases, persons who have been harmed as a result of the breach would not have to prove negligence to be awarded compensation. 

"This is designed to encourage people to comply with the law, and to improve the availability of compensation for anyone who has suffered harm because someone else has broken the law," the minister said.

Defences will be available for this strict civil liability rule similar to those already contained in the Act. 
The amendments to introduce a civil penalties regime would enable the State to take a civil prosecution or impose a fine for breaching the HSNO Act, whether or not the breach had resulted in any harm to individuals, the environment or to public safety. Similar to other legislation (such as the Commerce Act) the maximum penalty levels will be large to act as a deterrent to discourage non-compliance. 

"The government is committed to a robust regulatory mechanism, and part of this is having law that people comply with," Marian Hobbs said. "These changes to the liability regime under the HSNO Act are designed to secure compliance with that Act, thereby protecting the health of New Zealanders and their environment."
Amendments to improve HSNO Act operations The government has announced its proposed changes to the Hazardous Substances and New Organisms Act 1996 to improve the way it works for decisions on organisms that are new to New Zealand. 

The HSNO Act has applied to the management of new organisms since 1998 and the changes being made are a result of experience in the way the Act operates in this area. 

In general, the proposed changes clarify the decision making process for the Environmental Risk Management Authority (ERMA) and allow the Authority to make more accurate assessments of the risks posed by new organisms on a case-by-case basis.

For example, they would allow ERMA to make decisions on the risk posed by an organism at the sub-species or genus level as well as at the species level - a change that is significant for organisms such as bacteria, where some sub-species or strains within the same species are highly toxic to humans and animals while others are perfectly harmless.

Other amendments would introduce more realistic timelines, when these are needed, for ERMA to publicly notify its decisions and allow the authority the ability to order prompt compliance where enforcement officers have issued a compliance order for breach of the regulations. Currently compliance orders do not take effect for, at earliest, four days - except
in an emergency situation.
They also give ERMA the ability to declare that an organism is "no longer new" in cases where the organism does not have a HSNO approval but is well-established and is not subject to an eradication programme. However, the Environment Minister, Marian Hobbs stresses that this provision does not mean that smuggling is in any way being condoned.

"The change is designed to make sure people are not prosecuted for being in possession of new organisms which may have arrived by themselves rather than being introduced deliberately," Marian Hobbs said. "I want to make clear that this will not be used to legitimise the smuggling into the country of foreign organisms. On the contrary people can expect to be severely punished if they attempt to smuggle in new organisms."

As well, the changes being proposed will bring the requirements for containment of zoo and circus animals under the HSNO Act, replacing the Zoological Garden Regulations 1977, which expire in July this year. 

Marian Hobbs said the proposed rules will ensure a high level of containment for zoo and circus animals but will allow for the transfer and temporary absence of animals from containment for specialist veterinary care and to allow for breeding programmes. 

"We need these provisions in the interest of animal welfare and to allow New Zealand to play a role in conservation and biodiversity on a global scale. Our participation in breeding programmes is significant in helping international efforts to save endangered species that are not native to New Zealand," she said.

Other amendments would clarify the rules protecting confidential supporting information supplied in applications for ERMA approval when these become the subject of an Official Information Act (OIA) request.

The procedures for notifying applicants when there has been a request for information under the OIA would be strengthened and another amendment would more clearly define what is covered under confidential supporting information. 

"There have been no problems to date in this area, but as the amount of information being provided to ERMA increases, we need to ensure that the rules and definitions are clear in the Act," the minister said. About the Hazardous Substances and New Organisms (HSNO) Act 1996 The Hazardous Substances and New Organisms Act - generally known as the HSNO 

Act - was passed in June 1996 and was aimed at streamlining and updating the system for managing the risks from hazardous substances and new organisms (including genetically-modified organisms) in New Zealand. While it was passed into law in 1996, the HSNO Act came into force for new organisms in July 1998 and in July 2001 for hazardous substances (although for hazardous substances there is a transitional period during which those substances already legally in the country are being transferred to the new law).

The HSNO Act replaces the Explosives Act 1957, the Dangerous Goods Act 1974, the Toxic Substances Act 1979, the Pesticides Act 1979, and parts of the Animal (1967) and Plants (1970) Acts covering the intentional introduction of new species into New Zealand. It has also replaced two interim voluntary arrangements set up to deal with the relatively new technology of genetic modification.  

Under the act, a hazardous substance is one which, because of its chemical nature, could readily explode, burn, oxidise or corrode, or is toxic to people or other living things or to ecosystems. A new organism is a species of organism coming into New Zealand for the first time. The term 'organism' refers to any living thing, including animals, plants, microbes and viruses. The Act also makes all genetically-modified organisms new organisms, even if they are developed in NZ. 

The purpose of the Act is to "protect the environment and the health and safety of people and communities by preventing or managing the adverse effects of hazardous substances and new organisms." It does this by requiring a consistent assessment process for all hazardous substances and new organisms prior to their being imported, developed, manufactured or
released, and to enable public participation in this process. It also provides for a reassessment of whether new organisms and hazardous substances should be imported, developed,  manufactured or released where it is seen to be necessary, and assigns responsibility for monitoring and enforcement.

The Environmental Risk Management Authority (ERMA) is the quasi-judicial body which decides if new organisms and hazardous substances can be introduced into New Zealand. It manages any risks that hazardous substances and new organisms pose to the environment and public health and safety. 

The HSNO Act is enforced by a number of central government agencies and New Zealand's 74 territorial local authorities.

Fines for breaching the HSNO Act's main provisions include up to $500,000 for an offence and an additional $50,000 a day for a continuing offence. Offenders can be imprisoned for up to three months. A court can also order a convicted offender to remedy or mitigate the effects of the non-compliance at their own cost or to pay the cost of this being done. A court can also order a new organism to be destroyed. 

For more information on the HSNO Act visit www.hsno.govt.nz "Fast-track" for emergency medicines The government has announced changes it wants to make to the law to speed up the assessment and approval of animal and human medicines, vaccines and pesticides that contain new organisms - including genetically-modified organisms - or hazardous substances and that may be required in an emergency.

Generally, these must go through full assessment by the main decision making body, the Environmental Risk Management Authority (ERMA), including public notification and consultation before they can be used here. This means potential delays in bringing in medicines in a health or biosecurity emergency.

To overcome this, the government is proposing a new fast-track system to be used to deal with emergencies. Under this proposal decisions could be made to allow the products to be imported without the level of detailed information or full formal processes required under normal circumstances.

"This does not mean these products will not be scrutinised before the decision is made to use them," the Environment Minister Marian Hobbs said. "Rather experts will be charged with weighing up the relative risks and benefits in view of the situation at the time."

The fact that they have been given the go-ahead for release in a health emergency would also not affect their status as a new organism or hazardous substance. Once the emergency was over, a normal application would need to be made for the medicine, vaccine or pesticide to be used again.

"This is a vital area for New Zealand, especially in a world where bioterrorism has become a real threat and where the disease-free status of our livestock is vital for our valuable export markets," the minister said.

"The Royal Commission on Genetic Modification, in its July 2001 report, recommended identifying the medicines that might be needed in an animal or human health emergency and seeking prior approvals for them. 

"Government officials have thoroughly investigated that approach and found it is not possible. Among the problems they found were that there would be nothing to guarantee that a particular product would be available when needed, while giving pre-approvals to a vaccine for a disease like foot-and-mouth could raise questions in our overseas markets about New Zealand's disease-free status." 

The government has also put forward changes to the HSNO Act to streamline approvals for new medicines made from, or containing new organisms,  including genetically-modified organisms.

At present, these medicines have to be approved by Medsafe (for human medicines) or the Agricultural Compounds and Veterinary Medicines (ACVM) Unit of the Food Safety Authority (in the case of animal products) for safety, quality and effectiveness. They also have to be assessed by the Environmental Risk Management Authority (ERMA) in terms of risks to the
health and safety of people and the environment.

Under the proposed changes, ERMA could delegate the approval of medicines that met a set of criteria for 'low risk' to Medsafe or the ACVM unit alone. To maintain the integrity of the system, ERMA would set guidelines for approvals and regularly audit them.

Medicines containing new organisms that did not fit the 'low-risk' criteria would still require full ERMA approval, including public consultation.

"The Royal Commission on Genetic Modification found the dual approval system required of all medicines caused confusion and added to compliance costs for companies wanting to market these products," Marian Hobbs said.

"The changes we are proposing will ensure that the cost of obtaining approval to market animal and human medicines is not so high that it deprives New Zealanders of potential health and other benefits, but at the same time ensures measures to protect the health and safety of the public and the environment are maintained where appropriate." Proposals to streamline laboratory research using low-risk GMOs The government is proposing a series of amendments to the Hazardous Substances and New Organisms (HSNO) Act 1996 to streamline the decision-making process for contained laboratory research in genetically-modified organisms (GMOs) and to tighten the law relating to the regeneration of animals from tissue and to the modification of human cell lines. 

The proposed changes are in line with recommendations made by the Royal Commission on Genetic Modification in its July 2001 report.

The proposed changes would allow research institutions conducting low-risk GM research in the confines of the laboratory to make applications for approval on a project basis, rather than the present situation, under which they must make a separate application for each organism produced during a particular piece of research.

"The current approval process for the development of low risk genetically-modified organisms is unnecessarily complex, with applications being costly and time consuming to make," the Minister of Research, Science and Technology, Pete Hodgson said. "The result is that they have the potential to inhibit areas of research, affect the retention and recruitment of staff and even encourage non-compliance."

Other changes would allow the main decision-making body, the Environmental Risk Management Authority (ERMA) to delegate decisions on the importation of low-risk organisms to Institutional Biological Safety Committees (IBSCs)*. These committees already make decisions, under ERMA guidelines, on the development of these sorts of GMOs in contained laboratories.

The changes being proposed by the government would also tighten up the HSNO Act by including in the legislation the regeneration from tissue samples of animals not already present in New Zealand.

This would not stop researchers using this technique for animals already in New Zealand such as native species or farm animals. 
"When it was drawn up, the HSNO Act did not see the potential for this technology and, while it appears there is no work going on currently to introduce new organisms this way, we need to anticipate that possibility in the legislation to ensure the development of all new organisms is covered," Mr Hodgson said.

The changes would also bring under the act the genetic modification of human cell lines in the laboratory for bio-medical research. 
Human cell lines are groups of cells taken from human tissue and grown in a container in the laboratory. They are used for a range of research, such as testing the effect on human cells of potential new drugs. 

"This type of work with human cell lines is not regulated at the moment," the minister said, "and the consensus is it needs to be. This amendment would ensure any potential risks posed to human health and the environment by such work is adequately managed."

The amendment applies only to work being done in laboratories for bio-medical research. Any subsequent use of these cells for treating people would still require approval under health regulations and laws.  Genetic modification involving individuals is also not covered by the HSNO Act. It is currently prohibited and will be included in legislation now being prepared to regulate human-assisted reproductive technology.

Institutional Biological Safety Committees The Environmental Risk Management Authority (ERMA) is the organisation responsible for saying yes or no to applications to develop, test, import or release genetically modified organisms in New Zealand. However it can, under the HSNO Act, delegate decisions about low-risk genetic modifications being done in contained laboratories to Institutional Biological Safety Committees (IBSCs) based at certain research institutions. These low risk modifications are ones that are considered to pose little risk to public health and the environment and include experiments done in teaching situations where there is little point in using the ERMA's time to repeatedly approve the same project. 

IBSCs can only decide on work done in laboratory situations where the containment meets standards laid down in regulations. The types of modifications and the containment standards are specified in the same regulations under the HSNO Act. IBSCs have been approving low-risk experiments since 1982 when work in New Zealand using genetic techniques was in its infancy. At that stage, a voluntary scheme required that all experiments using the new techniques needed to be approved by the Advisory Committee on Novel Genetic Techniques (ACNGT), but that body delegated any with low levels of risk to the IBSCs.

In deciding whether or not to grant applications, the Committees must follow rules set by the ERMA, which also monitors their decisions on a yearly basis. Those rules stress the impartiality of the IBSCs. No one closely involved in any of the projects under consideration is allowed to sit on the IBSC and each Committee includes a member of the community with no ties to the organisation, and there must also be a system of consultation with local Maori. If the ERMA considers any IBSC is not complying with the rules, it can withdraw its delegation to make decisions.

For more information about the rules under which IBSCs operate, visit the ERMA website at http://www.ermanz.govt.nz/Applications/Decisions/Delegation-doc.doc Work progressing on Treaty principles amendments to HSNO The government says work is proceeding to decide how the Hazardous Substances and New Organisms (HSNO) Act 1996 can be amended to more appropriately reflect the Treaty of Waitangi relationship between Maori and the Crown. 

The work is in response to the report of the Royal Commission on Genetic Modification, which also includes a wider package of amendments to the HSNO Act and the establishment of Toi Te Taiao, the Bioethics Council.

The government last year set up a Maori reference group to advise ministers on amendments to the Act to ensure it reflects the Treaty relationship in meaningful and constructive way. 
"Their brief is to ensure that Maori values are given adequate and transparent weighting within the workings of the Act, and in particular in the decision-making processes," the Environment Minister Marian Hobbs said. "The group has indicated to me that it is focusing particularly on changes to the law which will help Maori involvement in a practical sense."

That group is due to report back shortly and the government expects to announce its decision on how the Act will be amended soon afterwards. Next steps The proposed changes to the Hazardous Substances and New Organisms (HSNO) Act 1996 announced today will now go to the Parliamentary Counsel Office to be drafted into a bill. That is scheduled to be introduced to Parliament by the middle of April and to be referred to a select committee where the public will again have an opportunity to make submissions on the proposed legislation. 

The Committee is expected to report back to Parliament by the end of August with any changes it believes need to be made before it moves to its final stages in the House. The aim is to have the amended act passed into law by October.

That is when a two-year constraint period preventing the Environmental Risk Management Authority (ERMA) from considering applications to release new GM organisms expires. The constraint period was agreed to by Parliament in 2001 to give New Zealand the time to prepare the law changes required to enact the recommendations of the Royal Commission on Genetic Modification.

To date, no GM organisms have ever been approved for release in New Zealand.