July 25, 2000
The Environmental Risk Management Authority (ERMA) has released its Decision on an application to field test genetically modified cattle. The application has been approved, with controls.
After setting controls, the Authority has concluded that the probability of escape from the containment facility is very low and that there is negligible risk to the environment or public health from keeping the cattle in the contained research facility.
The will be available on the ERMA New Zealand website from noon on Tuesday 25 July, or on request.
The Decision is not unanimous. A majority of the decision making committee favoured approving the application, subject to controls. One member favoured declining the application. This was related to taking account of the spiritual concerns expressed by the local hapu, Ngati Wairere.
The applicant, AgResearch Ltd, sought approval to produce and field test genetically modified cattle at its research facility in the Waikato. The application was to use the cattle for research purposes, not for release into the wider environment. It was part of a three-part proposal, notified in March 1999, 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. Parts 1 and 2 were approved in November 1999, but the committee adjourned its consideration while further information was sought on part 3. The application precedes the Moratorium on GM. See background, below.
The research programme includes 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, by AgResearch, was previously approved under the HSNO Act, by AgResearch's Institutional Biological Safety Committee (IBSC) under delegated authority from ERMA.
The Authority has already approved other field trials using copies of human genes, in an application last year by PPL Therapeutics Ltd to develop a manufacturing flock of GM sheep.
The approval is for 5 years and the Authority has imposed strict controls.
Controls:
- construction of two 2 metre high perimeter fences around the facility;
- installation of an electronic monitoring system on the inner fence;
- double tagging the GM cattle, including ear tags and a subcutaneous electronic microchip;
- maintaining a database to register and track all cattle in the research programme;
- milking the cattle under strict containment conditions ;
- disposing of cattle and any biological material through on-site burial, in such a manner which minimises leaching to defined aquifers, and following consultation with Ngati Wairere;
- prohibiting the removal of conventional cattle off the site, until 50 days after the completion of 3 negative pregnancy tests;
- disposing of all milk on site by either an effluent treatment digester, incineration or by spraying on to pasture after treatment to destroy any cells present in the milk;
The applicant is also required to establish a Working Group with Ngati Wairere, to enable Ngati Wairere to monitor the implementation and progress of the field test, and to provide a forum for the exchange of information on the science of genetic modification.
The total number of cattle in all three parts of the research programme, including GM and conventional cattle, is not permitted to exceed 200. All cattle are to be kept in secure containment in a MAF approved facility and managed in accordance with animal welfare regulations.
ERMA New Zealand Chief Executive, Dr Bas Walker said that the application was an important one for the Authority.
"While this application is only for a field test in a contained facility and not for release of the organism, we know that it generated considerable interest - and that there were strongly held views.
The Authority has had to deal with a complex and difficult issue, particularly those aspects related to Maori cultural values. That is why they decided to take the time to explore if the potential effects could be ameliorated. The result is that Ag Research and the local hapu have identified ways that they can work together on the management of the research programme, for example regarding the disposal of biological material in a culturally appropriate way. The Authority has recognised this and built it in as one of the controls on the approval. "
Further details:
| Dr. Bas Walker Chief Executive ERMA New Zealand Ph 04 473 8426 |
Karen Cronin Communications Manager ERMA New Zealand Ph 04 473 8426 OR Mob 04 918 4826 |
Background to the Decision:
The Environmental Risk Management Authority was established in 1996. It controls the introduction of new plants and animals, including genetically modified organisms, and hazardous substances to New Zealand.
The application 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 application was therefore inside the HSNO Act process well before the current voluntary Moratorium on Genetic Modification took effect, on 14 June 2000.
A public hearing on the proposal was held on 25 August 1999 and the Authority approved the first two modifications in November 1999. It then adjourned the hearing while further information was sought from the applicant and the local Maori hapu, Ngati Wairere.
They were asked to advise on the steps that might be taken to ameliorate Ngati Wairere's concerns about the proposed research programme. Under the Hazardous Substances and New Organisms Act the Authority had to consider the risks to the relationship of Maori and their culture and traditions with taonga. Both the applicant and Ngati Wairere concluded that the concerns could not be ameliorated. The Authority has noted however, that there are a number of measures which the applicant should pursue, as a matter of good practice, such as the disposal of offal and other biological material and these have been incorporated into the controls in the Decision.
The decision making committee of the Authority comprised:
- Professor Barry Scott, Chairman;
- Mr Bill Falconer;
- Dr Oliver Sutherland;
- Mrs Helen Hughes;
- Professor Colin Mantell;
- And an external expert on Maori tikanga, Mrs Leatrice Welsh.
For full information on the application, the submissions, the hearing and the decision and a full list of the controls can be found from the cattle feature page.