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.

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