GE gates swing open ... carefully

New rules will allow the commercial release of genetically modified plants and animals in just over a year. SIMON COLLINS explains how they will work.

Strict conditions that may make it easier to approve the commercial release of genetically modified organisms have been set out by the Government.

A 93-page discussion paper entitled Improving the Operation of the Hazardous Substances and New Organisms Act for New Organisms was posted yesterday on the Ministry for the Environment website, www.mfe.govt.nz.

It is open for submissions until November 15.

It proposes detailed rules to apply from October 29 next year, when the moratorium on releasing genetically modified organisms will end.

A new category of "conditional release" will make it easier for the Environmental Risk Management Authority (Erma) to approve genetically modified organism (GMO) releases, by allowing it to set conditions such as where and when the organisms can be released.

The document says New Zealand is "unusual internationally in requiring formal regulatory approval for GMOs".

The paper tries to balance public interests against commercial competitiveness, including commercial secrets.

Its main proposals include:

Conditional release

At present, Erma can only approve or reject applications for GM work. The document adopts a recommendation from last year's Royal Commission on GM to create a new category of "conditional release".

It proposes giving Erma power to set conditions such as:

* How many of the organisms can be released.

* Where they can be released.

* Buffer zones and other physical barriers.

* Requiring "terminator genes" so that the organisms cannot reproduce themselves and spread.

* Double fencing and electronic tagging for animals.

* Restricting use to a particular company or researcher.

* Restricting use to research, rather than commercial uses.

* Ensuring that new organisms are not eaten by other animals, birds or humans.

* Regular monitoring.

* How the organisms will be disposed of.

For example, an organism designed to make possums sterile might be approved for release in a particular region on condition that animals and plants in the area are monitored for any adverse effects.

The document says the Ministry of Agriculture and Forestry may be the best agency to monitor and enforce these conditions in most cases. Other options include the Conservation Department and regional councils.

Costs

The document says the Government has indicated its intention to recover all costs for Hazardous Substances and New Organisms Act (HSNO) applications, compared with 54 per cent cost recovery at present.

On this basis, it says GMO developers may have to pay for monitoring of their work under conditional release.

However, it says: "Issues of precedent, practicality, equity, consistency and the economic impact of further cost recovery would need to be carefully considered before any decision could be made."

The Crown-owned AgResearch institute says its latest application to insert genes from various animals into cows has already cost it almost $500,000 in legal costs and Erma fees, which start at $25,000 to $35,000. Erma is to announce its decision on that case by Monday.

GE-free zones

As an alternative to restricting a GMO release to a particular region, the document says, Erma "could be required to recognise decisions to be GM-free on the basis of locality or industry that have been made by some other body; for example, the relevant industry association or the local council".

"There are disadvantages to this approach in that other bodies do not necessarily have the expertise to assess the effects of new organisms," it says.

"Parliament has established special-purpose legislation (the HSNO Act) and a national, technical and non-political body (Erma) to carry out these assessments.

The HSNO process already involved a process for public input, giving citizens an opportunity to have their say.

"It would not be desirable to duplicate processes or change the basis for decision-making."

Low-risk organisms

Erma now delegates applications to develop "low-risk" GMOs in containment to "institutional biological safety committees" at six crown research institutes, six universities and four private companies (Fonterra, Carter Holt Harvey, Genesis Research and Development and Fletcher Challenge spinoff Trees and Technology Ltd at Te Teko, near Whakatane).

The discussion paper proposes giving these committees power to approve GM research projects as a whole, rather than requiring separate approvals for every GMO produced.

It would also extend the committees' powers to cover importing low-risk GMOs, as well as developing them.

Human cells

The HSNO Act does not cover imports of human tissues or genetic modification of human cell lines because the lawmakers did not foresee human cloning when the law was passed in 1996.

The discussion paper proposes closing this loophole by requiring approval for any genetic modification of human cells where those cells might be able to reproduce.

It says this could be done either by amending the HSNO Act or through health legislation.



Approval should also be required for "regenerating" an organism new to New Zealand from any local or imported tissue, even if no genetic modification is involved.

Liability for damage

A report last year by law firm Chen Palmer and consultant Simon Terry said GMO developers should have to take out insurance to cover the full costs of any damage arising from their GM work.

But the royal commission said insurance was likely to be unobtainable for some risks from GM work, so requiring it would be "a barrier to innovation and progress".

The discussion paper invites submissions on the issue, but does not recommend any special provisions for GM work.

"It would be inconsistent with the basic policy decision to proceed with caution to introduce mandatory requirements to obtain insurance of a kind that could not be obtained in practice."

Commercial secrets

The royal commission recommended that commercially sensitive information given in support of GM applications should have "appropriate protection".

The discussion paper offers various options, including ensuring that the person who supplied the information is contacted before any decision is made on whether to release it under the Official Information Act.

Medicines

Medicines containing GMOs must now be approved by Erma and the Health Ministry's Medical Devices Safety Authority (Medsafe). The royal commission recommended streamlining this process by giving Medsafe sole responsibility.

But the discussion paper says medicines containing GMOs should still be assessed on their risk to the environment, as well as to individual patients.

It says it would be inefficient for Medsafe and Erma to have environmental experts, so it would be more sensible to keep Erma involved in the process.

Cultural issues

Under the current law, the Minister for the Environment can "call in" any application that has significant economic, environmental, health or international effects or affects an area that is beyond Erma's expertise.

The discussion paper says "cultural effects" should be added to this list. This should include ethical and spiritual effects.

Timing

The document says Erma has often found it impossible to consider, decide and publicly notify decisions on major GM applications within the 15 working days now allowed. It recommends extending this to 30 working days.

This would increase the total period from an initial application to the final decision from 85 to 100 working days, or 20 weeks (five months).

Further reading
nzherald.co.nz/ge

GE links

GE glossary