Dialogue: Risk authority managing GE experiments as the law allows

BAS WALKER* says that rather than shooting the messenger, scientists involved in genetic engineering should focus on their legal responsibilities.

Comments in a recent Dialogue article by Dr Jon Hickford, of Lincoln University, that the Environmental Risk Management Authority is vilifying scientists and has raised public anxiety unnecessarily are completely unprofessional.

The authority works under the 1996 Hazardous Substances and New Organisms Act, through which Parliament decided to regulate all genetic engineering in New Zealand.

The act provides for low-risk genetic engineering developments to be approved through a rapid assessment process, delegated to scientific institutions.

On the other hand, genetically modified organism field tests and releases require more detailed assessment, are publicly notified and are considered by the authority itself.

Genetic engineering developments can be approved if they meet the low-risk criteria.

For example, experiments carried out using organisms which cannot survive outside laboratory containment, and which do not cause disease in humans, animals or plants.

When the act came into force in June 1998, the authority set up a process so that low-risk genetically modified organisms are decided by biological safety committees in research institutions.

The authority delegated its decision-making power to institutions as an efficient way of handling this kind of application.

It means that scientists can get a response on site and don't have to come to the authority in Wellington for an approval. Compliance costs are, therefore, significantly reduced.

Since then, over 400 genetically modified organisms have been approved by 21 institutions under delegated authority.

It is nonsense for Dr Hickford to suggest that the authority has failed to distinguish between low-risk genetic engineering developments and high-risk activities, such as field trials. In fact, we distinguish to the full extent that the act permits.

Reactions such as that of Dr Hickford are a classic case of trying to shoot the messenger because the message is unpalatable.

It is essential that scientists focus on the legal requirements and not waste time criticising the authority for implementing the act.

The recent situation involving unauthorised research was first brought to the attention of the authority by scientists themselves. The incidence of non-compliant research was reported to us by the biological safety committee of Otago University.

At the time, we said the committee had acted properly and responsibly. Senior scientific figures in the university also made it clear that it was unacceptable for genetic engineering work to be going on without the proper approvals.

Since then, the authority has completed a nationwide check of research institutions in the public and private sector.

A further 196 examples were found of genetic engineering research which had been approved under the old voluntary regime, before the Hazardous Substances and New Organisms Act, but which had not been properly gazetted under the new law. And a further 113 examples were found of work which went beyond the bounds of existing approvals.

The authority is completing its investigation into the reported examples, to verify if they are unauthorised and if any risks are involved.

A decision was made not to prosecute - but to work to ensure that all genetic engineering research was brought into the system.

In the meantime, decision-making powers in institutions were suspended until such time as the authority is satisfied that appropriate procedures are in place. This situation is temporary and we are moving to reinstate delegations. Five have been reinstated so far and others will follow soon.

The lesson to be learned from this is simple: there is an obligation on both scientists and the authority to see that the approval process under the act is followed. The fact is that the law of the land says that low-risk genetic engineering work should be regulated. This is not a policy position of the authority but the law as enacted by Parliament.

There is a public expectation that genetically modified organisms will be managed safely, and this is even greater now given the heightened interest in gene technology and the establishment of the royal commission.

Our prompt reaction to the discovery of unauthorised work has the support of science institutions and has ensured that we maintain public confidence. Having said that, we are aware of the scope for making improvements to the act. In many respects, we agree with points made by scientists about aspects of the procedure and would like it simplified.

We have made this known to both the previous and the present Government and will indicate to the royal commission on genetic engineering where we think efficiencies can be made.

Until such time as the law is changed, the approach we have taken is to avoid making extravagant statements while moving firmly and quickly to bring unauthorised work inside the framework of the act. And we would encourage all scientists to do the same.

* Dr Bas Walker is chief executive of the Environmental Risk Management Authority.

GE DEBATE - A Herald series

GE lessons from Britain

GE links

GE glossary

GE discussion forum