Cash cow, or mad cow?

By GEOFF CUMMING

One by one, the barriers to genetic research in this country are being lowered, smoothing the road to a GM future. And whether it is too late to turn back may hinge on the fate of cows carrying human genes at the Ruakura research station.

Approval this week for AgResearch scientists to experiment on Waikato dairy cows using genes from humans and other mammals is as much a breakthrough for our struggling biotechnology sector as it is a blow to the anti-GM movement.

The importance of the Environmental Risk Management Authority's all-clear for experiments, both in the lab and outdoors, is obvious from the rhetoric. Though it was in neither side's interests to trumpet the ruling's significance, scientists admitted it was a landmark and GM opponents were left to ponder the verdict of Green Party co-leader Jeanette Fitzsimons: "If they approve this, what won't they approve?"

Said one scientist: "The GM opponents now have to switch the attack from stopping experiments to trying to mitigate the risks of those experiments."

Greenpeace billed AgResearch's proposal as "the most controversial GE application New Zealand has ever seen", for several reasons. The crown research institute sought approval to create calf embryos using genes from humans, mice, deer, goats, sheep or cattle. It sought, and won, "generic" approval to decide as it goes along what new organisms it will create rather than having to seek approval for each viable embryo.

It is the first application involving animals since the GM Royal Commission, and the first under the amended Hazardous Substances and New Organisms (HSNO) Act. As such, scientists have grasped the approval as a symbol of Government encouragement for biotechnology.

AgResearch aims to produce cows which express milk containing therapeutic proteins. These proteins may counter a range of diseases, including multiple sclerosis. Genetically modified embryos will be transferred to conventional cows and the resulting transgenic calves tested to evaluate the success.

While opponents consider it a field trial, which should be more rigidly controlled, Erma considered it a development trial which could move beyond the lab to an "outdoor containment facility" - basically a high-security paddock.

This raises the possibility, say opponents, of horizontal gene transfer to birds and insects from the faeces of the GM cattle. They press panic buttons about the uncertain outcome of experiments using unknown genetic material on food animals in a country so dependent on agriculture.

This potential cash cow is mad cow science, using large animals as guinea pigs, they say.

Greenpeace's Steve Abel says the decision gives AgResearch open slather to mix and match genetic material.

"We're way ahead of ourselves. There's a huge amount of investigative work which needs to be done in the laboratory into how things work at this genetic level. This is an extreme shot-in-the-dark approach to science."

Abel says overseas efforts to develop therapeutic proteins in animals have proved expensive and futile. "And nobody wants to drink the GM milk produced."

But AgResearch and Erma stress that the approval does not allow the use of any therapeutic proteins produced. And Erma believes tight conditions will minimise the likelihood of transference and unforeseen side-effects. The conditions rule out the use of any DNA sequences which might produce known viruses, and cover the on-site destruction of GM cattle and disposal of treated milk.

AgResearch will still need to inform Erma about genetic materials it is using, and the potential gene products, before transplantation.

Erma chief executive Dr Baz Walker says the research is similar to previous applications by AgResearch to produce the human myelin basic protein in cattle at Ruakura, and by PPL Therapeutics using transgenic sheep at Whakamaru.

As a test case, the ruling shows others how provisions of the new legislation will be interpreted but is "not particularly earth-shattering".

"This is a far cry from general release," says Walker. "I always get very upset when people compare this with what might happen with an application for general release [after the two-year moratorium on commercial release expires next October]."

Nevertheless, GM opponents have much to lose if the decision stands, and they are considering an expensive legal challenge. Each approval raises the bar of public tolerance - and indifference to the next mind-boggling application.

As Walker points out, experiments with genetically modified organisms have been going on in New Zealand for 30 years.

"In all that time there's been not a single recorded instance of any harm to the environment."

Erma approved the AgResearch application in the face of 856 objections and just seven submissions in support.

Political scientist Tim Bale says the outcome casts doubt on the Greens' tactic of flooding every GM application with objections. This blocking tactic was to be the fallback position for GM opponents when the commercial release moratorium is lifted next year.

"It must be worrying for them that it hasn't worked. It leaves them with few other avenues other than the judicial review route, and that deals with process rather than revisiting the specific issues."

The ruling might boost Alliance moves for a citizens-initiated referendum on commercial release. But Bale says there are significant obstacles to a referendum and the outcome cannot be guaranteed.

"While people may have objections to putting human genes into animals, groups opposed to GE have to admit that as far as the public is concerned, there seems to be more support for experiments which promise medical rather than commercial benefits."

Fitzsimons says the Greens will press for Erma's treatment of applications under the HSNO Act to be included in a Government review of the agency, ordered after the GM corn contamination row during the election.

"We would change the act so that no experiments on GE organisms are allowed outside the laboratory - but we are not the Government."

She says the ruling takes New Zealand further towards a GE future "in the sense that applicants no longer have to tell Erma what it is they are going to do. It's like a fishing expedition.

"We have moved to a situation where this kind of experiment is permitted in this country. Whether anyone can do anything about it is up to the public."

The Greens would encourage people to make submissions on proposals for conditional release of GM organisms after the moratorium is lifted.

But Abel says the decision will deter opponents from making future submissions.

"If the Government thinks we are going to continue to participate in a farcical regulatory process like the Erma one, they've got another think coming.

"Who's got the time and energy to waste their breath with Erma? But the alternative, to not participate and let things go ahead, is very frightening.

"Energies will have to be spent in other places to convince the Government that the people of New Zealand don't want genetic engineering in our agriculture."

GE-Free New Zealand spokesman Jon Carapiet says the decision flies in the face of the royal commission's precautionary approach to using food animals where there are alternatives.

"It's research which exposes our agricultural industry to risk, such as the risk of prion diseases like BSE developing from misfloated protein.

"They haven't looked at the possible economic impacts of New Zealand losing its GE-free image in agriculture."

Not surprisingly, scientists take a very different tack, saying the decision will encourage investment in New Zealand's biotechnology sector.

A HortResearch programme leader, Richard Newcomb, says the case was a litmus test, as the first major approval since the royal commission.

"The encouragement is that approval has been given. It's not the floodgates opening - it may be perceived as getting us over the hump."

Newcomb says the ruling shifts the debate for opponents from "argument about approval to the actual workings of the approval".

"Scientists wanting to make a contribution to New Zealand can now see a pathway."

AgResearch chief executive Keith Steele says the Government has identified biotechnology as vital to New Zealand's economic growth.

Having more certainty about the future regulatory environment will help science research agencies and "remove one of the major barriers to overseas science investment in New Zealand", says Steele.

AgResearch can now complete negotiations with companies keen to develop particular therapeutic proteins.

"But I would like to move away from the perception that this allows us to go into our labs and do whatever we like. New Zealand has the tightest regulatory system in the world."

The decision also gives clear leads to those undertaking similar biopharmaceutical research using crops and medicines.

Tony Conner, research leader into GM vegetables at Crop and Food Research in Christchurch, says it extends the opportunities for outdoor research in a contained environment.

Crop and Food wants to begin field tests on GM plants including onions, potatoes, broccoli and forage brassicas.

"Until now we've had to go to Erma to field-test on a one-off basis at huge expense," says Conner, who represented AgResearch on horizontal gene transfer during the hearing.

"This gives us more opportunity to do sound science and ask more relevant questions. But it's still miles from any commercial application."

Francis Wevers, executive director of the Life Sciences Network, says the decision creates a precedent and will give New Zealand scientists, who already have a worldwide reputation for large animal research, further opportunities to show what can be done here.

"It gives huge opportunities for the dairy industry to shift from commodity-based milk products to something where the constituent parts of milk are able to be developed to produce added value."

Some of those possibilities are extremely sensitive commercially, but the decision means AgResearch will have to keep Erma informed.

"It's far from being open slather. There are only going to be certain genes of interest."

Wevers doubts that the approval will deter passionate GM opponents, who will continue to challenge future applications "as is their right".

"But it should send a signal that good science of itself is recognised as being of substantial benefit to the community, regardless of any economic benefits."