May 25, 2001
The Environmental Risk Management Authority (ERMA) has further considered the application from Ag Research to field test genetically modified cattle.
In a decision released today, the application has been approved with controls.
The High Court recently upheld an appeal on the field test - first approved in July 2000- on points of law. It set aside the original approval and instructed the Authority to reconsider the field test application with closer application of the 'Methodology' - a decision-making guide set down in regulations to the Hazardous Substances and New Organisms (HSNO) Act 1996.
The application involved inserting a synthetic human gene, which codes for the myelin basic protein, in dairy cattle. The aim of the research was to investigate the expression of the protein in the cows' milk. The transgenic cattle were to be kept in a contained trial area, under specified management controls, at Ag Research's Ruakura premises.
A special committee of the Authority has spent the last two weeks further considering the application. It has concluded that the benefits of the application outweigh the risks and costs- subject to it being managed under strict containment conditions. The application has therefore been approved with controls.
The decision was by a majority of the committee members, with one member taking a minority view. The key point of difference was in the significance given to the concerns of Ngati Wairere, the hapu with 'manawhenua' status in the local area.
ERMA New Zealand Chief Executive Dr Bas Walker said that the special committee was mindful of the judgement of the Court in carrying out its consideration.
"The Committee has been very careful to apply the provisions of the Methodology in its decision on this containment application. It also is important to remember that this is a field test and not a general release of a GMO into the environment."
The approval for the field test, which has been made under the procedures set down in the Act, comes into effect immediately.
For further information:
| Dr Bas Walker Chief Executive, ERMA New Zealand Ph 04 473 8426 |
Karen Cronin Communications Manager, ERMA New Zealand Ph 04 918 4826 |
Background information
The Environmental Risk Management Authority (ERMA) was established under the Hazardous Substances and New Organisms (HSNO) Act 1996.
It is an independent panel of experts, appointed by the Minister for the Environment. ERMA is a semi judicial body, whose main function is to regulate the introduction of new plants and animals, including genetically modified organisms, and of hazardous substances to New Zealand.
The original application from AgResearch Ltd was to field test a genetically modified organism in containment. It was first made on 11 December 1998 and, following additional information requests from ERMA New Zealand, it was publicly notified on 17 March 1999.
The applicant sought approval to produce and field test genetically modified cattle at its research facility at Ruakua. The application was to use the cattle for research purposes, not for release into the wider environment.
It was a three-part proposal, involving modifications to dairy cattle to:
1) insert additional casein protein genes;
2) inactivate the b-lactoglobulin milk protein;
3) insert a sequence that coded for human myelin basic protein (MBP),
so that MBP would be expressed in the milk of GM cattle.
A public hearing was held on 25 August 1999. Parts 1 and 2 were approved in November 1999, but the committee adjourned its consideration while further information was sought on part 3, including consultation between the applicant and local hapu, Ngati Wairere. Part 3 was approved in July 2000.
The research involves the development of cattle from embryos containing a gene sequence that codes for a human protein, the myelin basic protein (MBP). Cows containing this construct are expected to produce the human MBP in their milk. The gene construct is a copy of a human gene sequence. The copy was made from human DNA in an international gene bank. The development of the GM embryos was approved earlier by AgResearch's Institutional Biological Safety Committee (IBSC) under delegated authority from ERMA.
Under section 45 of the HSNO Act, the Authority may approve a GMO field test if it is for one of the purposes stated and if, after taking into account all the effects of the organism, the beneficial effects of having it in containment outweigh the adverse effects if it should escape; and it is satisfied the organism can be adequately contained.
In approving the field test in July 2000, the Authority imposed a range of containment controls.
It required that the total number of cattle in the containment facility (for all three parts of the research programme), including GM and conventional cattle, would not exceed 200. The actual number of GM cows present in the facility at any one time, up to the 200 limit, was an operational matter for Ag Research.
On 24 May 2001, Ag Research said that the process so far has included:
- 51 embryos transferred to 51 cows;
- 45 failed pregnancies;
- 6 cows remaining pregnant with 6 unborn calves.
It is understood that the cows are due to give birth in June.
The Authority's decision, as it related to part 3 of the research involving human genes, was appealed by a group of submitters in August 2000.
The appeal was upheld by the High Court on 2 May 2001. The original approval was set aside and the Authority was instructed to reconsider the application. Subsequently the Court granted a stay until 28 May 2001 which effectively re instated the original approval while the further consideration occurred, to maintain the legal containment status of the animals under the Act.
The special committee of the Authority, which reconsidered the application, comprised:
- Dr Oliver Sutherland, Chairman;
- Mrs Helen Hughes;
- Professor Colin Mantell;
- Mrs Leatrice Welsh, an external expert on Maori tikanga.
The application has not been affected by the voluntary Moratorium on Genetic Modification. It was already inside the HSNO process before the Moratorium took effect on 14 June 2000. The Moratorium is due to finish on 31 August 2001.
The Authority has already approved other field trial research using copies of human genes, in an application in 1999 by PPL Therapeutics Ltd to develop a manufacturing flock of GM sheep.
For more information on the cattle applicaton go to our focus page.