What applications can be made to ERMA?

Laboratory research and contained field tests

• understand how genes work
• develop resistance to diseases and pests in plants and animals
• improve plant and animal breeding techniques
• modify plants and animals to produce medical products
• identify genetic variation in endangered and other native species.

Some research is focused on finding ways to better control pests such as possums, to protect native animals and plants and control bovine tuberculosis. Other New Zealand research is aimed at improving crops (eg, to modify pine trees to produce more wood and less pollen, or to produce potatoes that are disease resistant). There is also research into the genetic modification of crops that are neither food nor medicines, such as changing flower colour in ornamental flowers.

Getting approval to use genetically modified organisms in research

The Hazardous Substances and New Organisms Act 1996 (HSNO Act) requires that anyone who wants to conduct research involving genetic modification must obtain approval. Approval is also required for the release of any living organisms that do not already exist in New Zealand, including any genetically modified organisms.

Research using genetically modified organisms must have approval from Environmental Risk Management Authority (ERMA). In certain cases where approval is sought for an application that meets 'low risk' criteria, ERMA may delegate authority to an Institutional Biological Safety Committee (a special committee within a research organisation) to assess the application. This may include research that involves experiments with certain types of organism such as microbes that do not cause disease. The laboratory research is subject to strict controls. The Act requires that an approval for genetic modification can only be given if strict controls are in place to prevent the organism escaping or causing harm to those who handle the organism. Laboratories must meet a certain level of containment before they can undertake certain types of research. The Ministry of Agriculture and Forestry (MAF) inspects research facilities to make sure the organisms are properly contained and the controls are being followed. An Animal Ethics Committee must also approve any research involving animals under the Animal Welfare Act.

Sometimes, research needs to move outside the laboratory; for example, to see how the organism would behave in conditions similar to those in which it might eventually be released. However, these field tests are not always intended to lead to general release or commercial use - a field test can be the end point of an experiment. When genetic research outside the lab is proposed, reasons need to be given why laboratory or non-genetic modification methods cannot be used.

What are the controls on field tests?

Field testing does not mean that a genetically modified organism is simply let out into the nearest paddock. The HSNO Act requires strict conditions to be placed on the field test to reduce any potential risks to humans, our environment, plants or animals. The genetically modified plants or animals are not allowed to escape or to be released outside of the trial area, access to the facility must be restricted and scientists must ensure that 'heritable material' (eg, seeds or cuttings) from plants does not escape from the field test site. All field tests must be inspected and monitored on a regular basis to make sure these requirements are being met.

Here is an example of the requirements for a contained field test of genetically modified pine trees.

• Trees taken from the secured laboratory for the field test are counted before and after planting in a securely enclosed field.
• Limits are placed on the numbers of trees planted in the test.
• Plants are carried from the secured laboratory to the contained field test site in closed, crush-proof packaging.
• Trees are destroyed at a maximum age of six years or sooner if they start producing pine cones.
• A few trees are allowed to grow beyond this age - in which case all their male cones are removed before they shed pollen. Up to 10 female cones per tree are allowed to remain, until they reach a certain maturity stage.
• All reproductive structures (cones) removed from the tree are transported back to the secure laboratory in a secure container and destroyed when no longer required.
• Trees no longer needed for the research are destroyed.
• The site has a security fence, and a record is kept of all people with access to the site.

Conditional and full release

The HSNO Act also provides for the release of new organisms, including genetically modified organisms, into the wider environment. In considering a new organism for release, ERMA must first decide whether or not the organism would be likely to have any significant effect on the environment or human health and safety, taking into account any conditions that could be placed on the release. ERMA must decline an application if it fails to meet these minimum requirements. ERMA then looks at any potential economic and other benefits and weighs these up against the risks. This cost/benefit analysis provides a basis for the final decision on whether or not an organism should be released.

There are two types of release approvals under the HSNO Act:

• conditional release
• full release.

Conditional release

After carrying out their assessment, ERMA can approve an organism for release subject to certain conditions. In the case of crops, these conditions might include restrictions on where the genetically modified crop can be grown, compulsory buffer zones between the modified crop and conventional crops, regulations on the planting (and therefore flowering) time, or controls on how the crop is harvested and processed.

In the case of genetically modified animals, conditions could include a limit on the number of released organisms, high-security fencing and requirements for disposing of wastes.

Conditional release may be for commercial purposes, but may also be part of the development of a genetically modified organism. For example, scientists may need to know how a modified organism behaves and performs in the wider environment and in a variety of situations - something that is not always possible in a more confined field test setting.

The Ministry of Agriculture and Forestry is the agency that will enforce compliance with conditions laid down by ERMA.

Figure: Assessment process for releasing GM organisms in New Zealand

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Full release

Where ERMA sees that a new organism has no potential risks that need to be managed by the imposition of conditions, it may grant a full release. At that stage, the organism is no longer considered new to New Zealand and is no longer subject to the Hazardous Substances and New Organisms Act, which means it can be grown, used or held anywhere in New Zealand.

In summary, ERMA can only approve an application for conditional or full release when:

(a) It has complete information about the environmental, public health, economic and social impacts of the genetically modified organism; and

(b) release of the genetically modified organism meets strict environmental and public health standards set out in law; and

(c) the benefits of the application outweigh the risks.

ERMA's decision to approve or decline an application can be appealed to the High Court. If the application goes ahead, conditions are monitored, enforced and amended as necessary by the Ministry of Agriculture and Forestry and ERMA.