By ANNE BESTON
Six calves genetically modified with human genes have been living quietly in a security compound for more than a year, their initial notoriety overtaken by contaminated corn scares and political manoeuvrings in the wider GM debate.
But now AgResearch, the state-owned science institute near Hamilton that created the calves, is back with a new request.
It wants the Government's gene science watchdog, the Environmental Risk Management Authority (Erma), to let it test a range of other genes in cows.
Not just genes from humans this time, but from sheep, deer, mice and goats.
Again, the research aims to produce proteins for medical research - and also let scientists monitor and study transgenic animals.
A three-day public hearing on the application starts today in Hamilton.
Both sides of the GM debate see the case as a test of the Government's new controls on genetic modification.
Green Party co-leader Jeanette Fitzsimons is among the 856 opponents. Only seven submissions were received in support.
AgResearch's original experiments involved inserting a synthetic copy of the human myelin basic protein gene into the cattle genome.
This was intended to produce enough of the protein to be tested as a possible cure for multiple sclerosis.
The institute says it has two "broad objectives" in the new research.
One is to develop transgenic cattle that can produce functional therapeutic foreign proteins in their milk; the other is to develop transgenic cattle for gene function and genetic performance studies.
The application, and the immediate criticism it drew, looks likely to entrench beliefs on both sides of the GM debate.
AgResearch has upped the ante by widening the scope of the research while declining to be too specific about exactly what the aim is.
The anti-GM lobby was quick to counter-attack, saying the "blanket" application was made so the institute could test its ability to produce transgenic animals.
Once they were created, the institute would cast around for a use for them.
Fitzsimons, a long-time critic of AgResearch's work in this area, doesn't believe Erma should have accepted the application.
"They have not described the biological material they wish to use except in the most general terms, like pretty well any gene from five different mammals including humans.
"So I don't think you can consider the risks, as Erma is meant to do, if you don't know what the gene is."
Erma is a bit nervous on this point.
In its evaluation of the application, it says while only one type of physical organism, Bos Taurus - the cattle - will be genetically modified, it will be modified by genes from any one of five other organisms.
Erma's report points to "jurisdictional difficulties" with this because "it leaves unclear exactly what the authority is asked to give approval for".
"It may also be difficult for the authority to consider all the effects of the modifications when it does not know precisely what the modifications will be."
But in the end, Erma says, that issue is one for "analysis and judgment rather than a matter of law".
That is designed to snuff out the anti-GM lobby's hope that a legal challenge to be mounted on that basis will succeed.
Wellington accountant and environmental consultant Wendy McGuinness has hired lawyers to appear at the beginning of the hearing to challenge whether Erma can rule on an application that is so unspecific.
Another big issue at this hearing is whether AgResearch's application can pass muster under changes to the Hazardous Substances and New Organisms Act, passed by amendment in Parliament this year.
The changes affect clean-up after a field test (a definition which legally covers AgResearch's application), and introduce extra decision-making considerations and inspection and monitoring controls.
Although the new provisions were mainly designed for field trials of food crops, some will apply to the cows at AgResearch's Ruakura facility.
The decision-making considerations include adverse effects on human health and safety and the environment, alternative methods of achieving the research objectives with fewer adverse effects, and effects arising from the transfer of genetic elements.
AgResearch will also have to inspect and monitor the area the cows will be held in more frequently under the new legislation.
It is too early for this application to have to pass one other test, the yet-to-be-set-up Bio Ethics Council.
That was a promise of the Labour-Alliance Coalition last year after it was found the HSNO Act didn't require Erma to take account of Maori concerns about GM. The council will do that, but not on this application.
Life Sciences Network chairman Dr William Rolleston plays down differences between this application and the earlier one. But he says the application's broad scope is a test for Erma.
"AgResearch doesn't want to have to go back to Erma every time and go through exactly the same process when doing essentially the same thing, it's a waste of resources," he said.
"It's going to be an interesting test for Erma about how it functions under the new legislation and new guidelines."
AgResearch says genetic modifications of the cattle "will be in the natural range of variation observed in cattle".
Erma's , evaluation report does not agree.
"Some of the modifications proposed in this application will permit the introduction of any genes from humans, mice, sheep, deer or goats ... and Erma New Zealand does not consider that this could be viewed as part of the normal variation observed in cattle."
Taking part, albeit involuntarily, in experiments of this kind can certainly be tough on Bos Taurus.
Placental abnormalities, high birth weights, behavioural abnormalities and premature death are just some of the risks for the animals involved.
How it works
The first step in AgResearch's proposal will involve working with cell cultures in the laboratory.
Scientists will use cloning techniques to produce genetically modified embryos that can be implanted into female cows.
The cloning can be achieved by splitting the cells of an embryo (to create identical twins) or more likely by cell nuclear transfer.
In this, the animal cell is genetically modified. Then the nucleus of the modified cell is transferred to an egg cell that has had its nucleus removed.
The cell develops into an embryo, which is transplanted into the uterus of a cow.
AgResearch says that if normal gestation follows, breeding and milking of the resulting genetically modified animal will be done in the second and third years.
Scientists will induce lactation (milk production) in the GM cows after 16 months.
The first natural lactation will take place after three years.
Scientist will then assess whether enough milk and protein are being produced.
AgResearch says the experiment will not take more than 10 years.
Successful production of the transgene could lead to an application to expand the herd and test it under normal farm conditions.
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Mixing 'em up out in the cow shed
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