October 31, 2000
The Environmental Risk Management Authority has approved an application from AgResearch Ltd to field test genetically modified sheep. Up to 100 sheep in three flocks will be field tested in a registered containment facility at Ruakura near Hamilton under conditions set down by the Authority, for a period of 5 years. The facility will be monitored by MAF.
In a majority decision, the Committee concluded that it was very unlikely that animals would escape from the containment facility and that the risks to the environment and human health from any possible escape were negligible, given the nature and extent of the containment and the sheep management regime set out in its approval. The Authority also noted that this was a scientific trial in containment and at no stage will any genetically modified material be permitted to enter the food chain.
The Minority decision was that the application should be declined on the grounds of the cumulative adverse effects on the local hapu, Ngati Wairere; that it is inappropriate for the applicant themselves to conduct the assessment of cultural effects; and that the proposed benefits of scientific information do not outweigh the possible adverse effects on the health and well being of the animals involved in the research programme.
ERMA New Zealand controls the introduction of new plants and animals, including genetically modified organisms (GMOs), and hazardous substances, to New Zealand.
The application involves modifying the sheep to inactivate the myostatin gene, to increase understanding of myostatin function in order to identify the effects on sheep muscularity. It has been approved with a wide range of controls, including:
- The indoor and outdoor containment facilities are to be managed in accordance with MAF and ERMA New Zealand approved containment standards.
- The sheep are to be managed in accordance with the Animal Welfare Act 1999; animal welfare and ethics guidelines administered by MAF and the Ag Research Animal Ethics Committee.
- The husbandry of the animals is to be overseen by an experienced veterinarian who shall have the power to determine a humane endpoint for any part of the trial or the overall endpoint of the trial.
- The outdoor containment facility is to be enclosed by a double perimeter fence, with an inner fence electronically monitored and alarmed.
- All sheep no longer required for breeding, and any biological material (including semen, ova, milk, and shorn wool) are to be disposed of on site under the requirements of the MAF/ERMA New Zealand Standard; the Resource Management Act; and in consultation with Ngati Wairere to develop culturally sensitive mechanisms for disposal.
- All sheep in the field test are to be double tagged; with GM ewes also implanted with an electronic microchip and GM rams fitted with a permanently fixed radio tracking device.
- Full details of the controls can be found in the Decision text or on request.
The Authority noted that the principal benefit of the research is the scientific information to be gained and increased understanding of the myostatin function. It said the proposed research is a legitimate and valuable scientific endeavor. While longer term there may be other benefits, the Committee said that at this point it would be premature to speculate on what those might be.
The Committee acknowledged the seriousness of the issues raised on behalf of Ngati Wairere and weighed them carefully. But the Majority decision did not consider that these matters were such to justify declining the application.
In terms of potential risks, the Committee noted the concerns raised by submitters about horizontal gene transfer but considered this to be negligible. It noted that there is no intention for the meat, milk or offal from the sheep to enter the human food chain - but if products from the GM sheep were ingested, it was extremely unlikely to present any ill effects and that the neomycin resistance and puromycin resistance gene products involved do not pose any allergenic concerns.
In response to a legal argument raised by a submitter about animal welfare issues, the Committee concluded that there was a jurisdictional gap in the Animal Welfare Act 1999 in relation to fetuses that are less than half way through their term. Nevertheless the Committee was satisfied that the Ruakura Animal Ethics Committee had considered all the issues arising from the modification of the sheep embryos. And it has placed controls on the field test to avoid unacceptable suffering of the animals.
The development of the GM sheep embryos was earlier approved by the Ruakura Institutional Biological Safety Committee (IBSC), under delegated authority from ERMA. The present proposal was to field test the sheep in a contained facility on Ag Research's Ruakura site, operated under containment standards for animal health and welfare developed by MAF and ERMA New Zealand.
The application was already in the system and was therefore unaffected by the government's voluntary moratorium on GM field tests which came into effect in June of this year. It was first notified in December 1999 and attracted 80 submissions, which were considered at a public hearing in April 2000. Further information, including the full text of the Decision and the application documents can be found on the ERMA New Zealand website or on request.
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Dr Bas Walker |
Karen Cronin |