12 November 2001 Hon Marian Hobbs Speech Notes
North Shore public meeting: Genetic modification, Sunnybrae Normal School, Northcote, Auckland 6.45pm Monday Nov 12

At the end of October the Government announced its key decisions on the recommendations of the Royal Commission on Genetic Modification. Today, I want to talk to you about those decisions in some detail and to outline next steps. I also want to talk about genetic modification in the context of what’s important to me as Minister for the Environment – that is, in the context of my goal for the environment, which is to make our clean, green image a reality.

The Government’s decisions
The major theme of the Royal Commission's report is “preserving opportunities”. The Commission thought it unwise for New Zealand to turn its back on the potential advantages on offer from genetic modification, but – and this is important – recommended that New Zealand proceed carefully and implement genetic modification cautiously, minimising and managing risks.

The Government supports this overall strategy of preserving opportunities. At the heart of our decision is concern about the health and safety of all New Zealanders and their environment. Because genetic modification is a relatively new technology, we need to ensure we are cautionary about how New Zealand proceeds. Our decision is a balanced one. It means that extra steps will be taken to protect our health and environment, but it also recognises the need to have knowledge and innovation drive our future as a nation. Our decision will ensure that responsible science continues to play a key role in the development of New Zealand into the 21st Century.

However, we have come to some different conclusions than the Royal Commission as to how the overall strategy of preserving opportunities should best be implemented. The differences are in two main areas:

 The first is the extent to which commercial release of live genetically modified organisms (or GMOs) should be possible in the immediate future.
 The second area is the conditions under which contained field testing research of GMOs should be able to proceed.

A restricted period on the release of GMOs
The Government believes that there should be no releases of GMOs until changes are made to the Hazardous Substances and New Organisms Act, (commonly known as the HSNO Act), and analysis and research identified as necessary by the Royal Commission are done.

Under the law as it stands, if a GMO is to be “released” in our country, that means an application must be made to the Environmental Risk Management Authority – that is, ERMA. The ERMA must carefully assess the GMO and decide that it is safe in terms of public health and the environment for it to be used or released in New Zealand. If this approval were granted, the GMO would be used without environmental controls. There have so far been no applications for release of GMOs in New Zealand.

GMOs have been released in other countries and include crops – for example, corn that is genetically modified to be resistant to certain insects is commercially grown in the United States.

Let me repeat what I have just said; there have been no GMOs released in New Zealand.

And although we’re not expecting any applications to be made to ERMA to release GMOs in the near future, especially for genetically modified crops, we don’t want to wait around until that first application is made before deciding how to act. We want to be absolutely certain that no applications are made and considered while we look into the economic implications and safety of GMOs generally, and while enhancements are made to the HSNO Act.

So, we are currently drafting a bill that will change the HSNO Act. This bill will put in place a two-year constraint period during which time no applications can be lodged with ERMA to release GMOs.

Exception – human and animal health benefits
There is an important exception, however. Applications to release GMOs that will give direct benefits to human health or animal health, or that are to deal with a serious emergency will be able to go ahead. What this means is that if someone wants to introduce an effective medicine that is also a live GMO – a vaccine for example – then an application can be made to ERMA to have that medicine assessed and considered for use in New Zealand. ERMA’s assessment would look at the environmental risks. Medsafe, the normal regulator for all medicines, would also assess the medicine in terms of its effectiveness and safety for humans.

If someone made an application to ERMA to release a GMO medicine, the exemption will also require that:

 Applicants provide additional information demonstrating that the GMO medicine cannot persist viably in the physical environment beyond the human or animal being treated with the medicine (in other words, even if it got out into the environment it would die off).
 ERMA take account of relative efficacy, safety and ecological effects. That is, ERMA would compare this medicine against alternative medicines.

In summary, it will be possible to apply for approval of a genetically modified vaccine but such an application would be subject to very strict scrutiny both from the point of view of the environment and human safety and from the point of view of its effectiveness as a medicine. Similar provisions apply to animal vaccines.
Changes to contained research
So that is the first important change we are making to the current law. The second area concerns enhancing the way in which contained research is controlled.

Before moving onto the changes that will be made to the HSNO Act in this area, I want to talk to you about what exactly this contained research is.

First of all, contained research involving genetically modified organisms is not new to New Zealand. It has been going on since the mid 1980s. Initially it was done under a voluntarily controlled regime, but for the last three years the research has been controlled and monitored under the HSNO Act. So that’s my first point, contained research is underway in New Zealand.

The second point I want to make is that there are two types of contained research:

 Developments undertaken inside a secured laboratory, and
 Research undertaken in contained field test conditions.

There is a lot of confusion about the latter, and this is not helped by the various names it is given. It has been called field trials in the media and the HSNO Act uses the term field testing. Contained field testing is not large areas of GM crops waving around in farm like fields, spreading pollen, seeds etc into the wider environment. This confusion seems to come from some other countries where field trials are done in this way. The reality is that under our laws field testing is a type of research activity that takes place where the organism (plant or animal) is exposed to the environment but under very strict conditions that ensure that the GMO cannot escape. In order to have this happen field test areas are generally quite small. The sorts of controls that are placed on these field tests include:

 Destroy or enclosing the reproductive parts of plants, e.g. removing flowers before pollen forms.
 Restricting access to the containment facility, so unauthorised people cannot carry away any reproductive material, and risk spreading the GMO beyond the research site.
 Excluding animals from the facility, so that they cannot accidentally remove reproductive or other material from the research site.
 High security fences special tagging systems for animals.

Controls are regularly inspected both during the research and sites are always check for long periods after it is complete to make doubly sure there is nothing left.

If you’re interested, details of these controls can be read on ERMA’s website (www.ermanz.govt.nz).

Genetically modified pine trees
To get an understanding of this, let’s look at an example of how a real field test is controlled. There is a field test of genetically modified pine trees underway and in this case the controls can be summarised as:

 Trees that are taken from the secured laboratory for the field test are counted, and then counted again when they are planted in the contained field.
 There are limits on the total number of trees allowed to be planted over the entire approval period (in the case I am describing it’s a total of 330 over the entire trial).
 Plants must be transported from the secured laboratory to the field test site in packages that are closed and non-crushable.
 Most trees have to be destroyed at a maximum age of 6 years or sooner if reproductive structures (e.g. pine cones) start to grow.
 There are strict controls on the trees that are allowed to grow beyond this stage – all male cones have to be removed as soon as they are detected; and only up to 10 female cones can remain on a tree until they reach a certain growth stage.
 All these reproductive structures removed from the trees must be transported in secure containment back to the secured laboratory or destroyed. Trees no longer required for the research also have to be transported and destroyed in a similar manner.
 To keep unwanted people and organisms from the trial site, it is fenced and a record must be kept of all people with access to the site.

I hope you can see from this example that field testing research is at present strictly contained and monitored.

This example also illustrates the Royal Commission's conclusion that the regulatory framework governing research involving genetic modification is sound. It concluded that the case-by-case approach taken by ERMA under the HSNO Act, supported by the range of containment provisions, provides a strict and rigorous regime. I would also point out that under this regime deciding on whether or not to have a field test allows for public input, and requires consideration be given to the principles of the Treaty of Waitangi. The ERMA must also consider the need for caution where there is scientific and technical uncertainty.

However when we looked at this system as it is written into law, we found that at present the ERMA has some discretion to determine all the conditions to be applied to approved research. I would have to say that the ERMA has always exercised that discretion in a way that has led to high security on the 6 field trials currently in progress in New Zealand.

However as an added safety measure the Government has decided make it absolutely clear that all research must meet the strictest safety (or containment) standards. The HSNO Act will be amended to require specific mandatory conditions to be applied to any future research approval.

This will include explicit conditions on contained field tests of genetically modified plants and animals to ensure that:

 Once a plant reaches the stage where it is capable of releasing heritable material (e.g., seed or pollen), any reproductive structure above the ground, such as a flower, must be securely contained or immediately removed and destroyed.
 Any plant heritable material beneath the ground (e.g., potatoes) must be either destroyed once the test is complete or dug up and retained in conditions of high security.
 All plant material associated with the trial must be removable from the site, that is it must be able to be destroyed on site or taken away and secured or destroyed.
 Any animals involved in field tests, including their offspring, must be held in secure containment and clearly identified so it can be easily identified and retrieved if it escapes.

In addition to this we will be requiring a strict and compulsory inspection programme for each field test.

In short, we already have the strictest controls in the world for contained research and, through this bill being developed, we are making them stronger.

We expect these law changes to be made by early next year, but importantly, the changes are effective as of 29 October, which is when the Government made its decisions. Anyone wishing to make an application to ERMA will do so in the knowledge that these additional measures are effective from the end of October. It’s important for the law change to occur as soon as possible so that all of us are clear about what applications can and cannot be made, what the possible exemptions are (such as for GMO vaccines), and what additional controls will be placed on contained field tests.

Work over the 2-year timeframe
So what will the Government be doing over the next two years, while this restricted period is in place? There are a number of important things all aimed at enhancing the system for controlling genetic modification and getting better information about it. The main pieces of work are to:

 Establish or strengthen research programmes looking into areas of social, economic, ethical, environmental and agricultural issues.
 The Government will explore coexistence and conditional release frameworks as far as is practicable in the absence of releases.
 Put in place many of the amendments to the HSNO Act, which the Royal Commission recommended. This includes the legal parts of the conditional release framework, and some streamlining of the system for approving work in secured laboratories. .
 Establish Toi te Taiao or the Bioethics Council to advise, provide guidelines and promote dialogue on the cultural, ethical and spiritual issues associated with biotechnology.
 Further investigate the liability system for genetic modification related issues. Specifically the Government will be looking at how to include this in the Law Commission's work programme. This will ensure that any potential problems with the existing liability system are identified and addressed proactively, and more importantly visibly and transparently.
 Develop a biotechnology strategy. The strategy will ensure that New Zealand keeps abreast of developments in biotechnology, with a mechanism to ensure ongoing balance between benefits and risks. On the other hand some of you may be aware that the Royal Commission recommended the setting up of a Parliamentary Commissioner for Biotechnology: We do not intend to do this although we do think that some of the tasks envisaged for the Commissioner are useful and we will be considering other ways to do these.

Conclusions
So where does this leave us in managing genetic modification:

 The Government supports the overall strategy of preserving opportunities as recommended by the Royal Commission. This decision is based on ensuring the health and safety of all New Zealanders and their environment, and it is a cautionary approach.
 Our decision is a balanced one. It means that extra steps will be taken to protect our health and environment, but it also recognises the need to have knowledge and innovation drive our future as a nation.
 Applications to release GMOs will not go ahead for two years – unless they offer important human and animal health benefits.
 Controls on contained research will be enhanced.
 The work over the next two years will give us information about social, economic and environmental impacts of GMOs, it will explore policy options for the future, and further changes will be made to the HSNO Act to enhance it.

Throughout the next two years while this work is developing, there will be many opportunities for you to participate in making the system better. I hope that those of you with interest in this area will continue to keep informed and involved in this very important issue.

Let me conclude where I started, my goal for the environment is to make our clean and green image a reality. As a matter of priority, this includes creating and implementing a sustainable and long-term strategy for New Zealand’s approach to genetic modification. It means ensuring that our management of genetic modification gets the balance right. We cannot shut our eyes to this technology, genetic modification has been happening (in containment) in New Zealand for the last 13 years. As a country dependent on our biological production systems (farms forests and fishing to name but a few) we need to keep up with and understand the science in this critical area.

It also means utilising genetic modification where the benefits are clear. This is already happening in the health field – for example insulin for the treatment of diabetes is derived from genetic modification – and it may happen for the environment. The most well known genetic modification research that may help us manage the New Zealand’s environment involves fertility control for possums. This work is all in containment of course. Landcare Research is investigating the possibility of such control, which may result in environmental benefits in terms of reduced use of poisons such as 1080 and reduction in damage to forests by possums. There are also associated benefits in controlling the spread of bovine tuberculosis, which is carried by possums, affecting our cattle and deer herds. However, such benefits, if they eventuate, are a long way off.

At the same time we are determined to minimise the risks to people and the natural environment. We want to protect New Zealand’s indigenous plants and animals, and we want to ensure that farmers, including organic farmers, are able to choose what production systems they use.

When it comes right down to it, this does mean proceeding with caution and this is exactly what the Government is doing.

Thank you for listening.

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