Scientists say it's time to let GM genie out of the bottle

By Chris Barton

John Lowenthal is praising chickens - in particular the broiler variety which takes just 42 days to grow from egg to maturity. The extraordinary bird, bred to grow big, fast and plump for our dinner tables, could undoubtedly play a significant role in fighting world hunger.

Especially because the Australian scientist and his CSIRO research team at the high security Australian Animal Health Laboratory in Victoria may just have the technology to breed an avian flu-resistant chicken.

It's early days, he tells his audience at last week's 10th International Symposium on the Biosafety of Genetically Modified Organisms in Wellington.

But the proof of concept project signals the cutting edge of genetic modification - gene silencing to create a resistance to viral infection which is then integrated into DNA, so it's passed on in future generations through normal breeding.

If it works, the avian influenza virus - which in its H5N1 strain has led to 240 reported human deaths in 15 countries - could be stopped in its tracks.

Genetic modification - aka genetic engineering - in animals is perhaps the most controversial frontier of this burgeoning new science that reconstructs genes, most often by taking DNA code from one species and putting it into another.

But it's this sort of advance - combating bird flu - that is changing public perceptions about a technology many view as too dangerous to be messing with.

It's worth noting, too, that the big broiler chickens Lowenthal praises - some of which have attracted animal welfare concerns because they seem too heavy to stand on their own feet - are created not by GM but by conventional breeding methods. And the GM intervention that Lowenthal proposes could be used across a range of animals to breed disease resistance.

GM advances don't stop there. The breast cancer drug herceptin comes via a genetically modified pathway. So does insulin - produced from genetically modified bacteria that are identical in structure to the insulin found in the human body.

There are also vaccines for cholera and hepatitis B produced using genetically modified bacteria acting as chemical factories. And other medicines, such as the anti-viral drug interferon - used for treating multiple sclerosis and cancer - is also a product of a GM process.

Technology messing about with goat genes has also enabled the production of ATryn, the first commercial recombinant form of human antithrombin, an anticoagulant which prevents blood clots. Yes, goats. American company Biotherapeutics, is harvesting - "biopharming" - antithrombin from goat's milk produced by a transgenic herd that originally hailed from New Zealand.

But if genetic modification can do so much good, why are we so much against it? New Zealand runs one of the strictest regulatory regimes controlling genetic modification in the world.

The legislation - the Hazardous Substances and New Organisms (HSNO) Act overseen by the Environmental Risk Management Authority (Erma) - is seen by many as a defacto moratorium on genetic modification. Since provisions relating to new organisms took effect in July 1998, just 16

GM contained field tests have been approved. Prior to this 50 GM field tests had been approved by the Minister for the Environment.

Among the 16 allowed were approvals to test GM cows modified to express the human lactoferrin protein in milk, GM onions modified for resistance to the herbicide glyphosate and GM brassicas (cabbages) for resistance to insects. None of the field tests have proceeded to commercial application.

Meanwhile the rest of the world ploughs ahead. Some 114 million hectares of GM crops were grown last year across 23 countries by 12 million farmers - the bulk of which were in resource poor areas.

Closer to home, the Australian Gene Technology Regulator has issued 64 licences, including 10 for commercial-scale releases: six for insect-resistant or herbicide-tolerant GM cotton, two for GM canola, one for GM carnations and one for a GM cholera vaccine. Limited and controlled

releases have been approved for 12 other plant species with a range of modifications including wheat (drought tolerance), bananas (enhanced nutrition), pasture grasses (improved forage) and rose (flower colour). Trials have also been approved for GM viral vaccines.

Costs - starting at a $35,000 plus GST but mounting to several hundred thousand dollars in time spent by staff and lawyers preparing an application - are one reason so few field trials are under way here. The time involved, including public hearings and consultation with Maori, is another.

Most applicants can expect a year-long process, but in one case it took two years. And this is just for contained field trials. Many scientists the Herald spoke to felt that not only would an application for commercial release never see the light of day, they simply didn't have the resources for such a battle.

It was a common lament among international delegates at the Biosafety Symposium too - that the burden of regulation has meant that only very large companies with very deep pockets had the resources to play the GM game. Little wonder that players such as Monsanto and Syngenta are able to wield such control in the market.

But New Zealand suffers from a further disadvantage - widespread public disapproval of the concept of GM. The concern, some would say fear, led to the 2001 Royal Commission on Genetic Modification which resulted in an overall policy of "proceeding with caution while preserving opportunities".

What we got was extreme timidity and opportunities few and far between. As Erma decision-maker Dr Max Suckling told the symposium, a new approach to GM in New Zealand would require a shift in the risk framework of the legislation - a change in some degree to its precautionary principle. "Our legislation is very risk-averse."

Risk aversion features strongly among New Zealand lobby groups - so much so that they want GM stopped dead. Two Crown Research Institutes have had field tests destroyed by anti-GM activists who have broken into secure areas and pulled up crops and cut down trees.

And in October, AgResearch's application to Erma to field-test transgenic animals was derailed by court action seeking a judicial review. AgResearch wanted to pursue the same line of research that Biotherapeutics, with its goats, has followed in the United States.

"Our main focus has been the production of proteins in milk," says AgResearch senior scientist Goetz Laible. The aim was to produce transgenic animals that could be bred to produce health-boosting milk - laden with human biopharmaceuticals, proteins, or antigens, enzymes, and hormones that will be useful for human health.

AgResearch is also investigating GM to fight animal diseases such as mastitis in cattle, and for finding ways to alter milk composition such as reducing allergens and modifying fat content.

GE Free NZ in Food and the Environment, which has filed the court action due to be heard in March, argues AgResearch's application is too generic and Erma, in allowing it to proceed, has made errors of law.

AgResearch's applications seek approval for any species within nine livestock genera (cows, buffalo, sheep, pigs, goats, llamas, alpacas, deer, and horses) and for several genera of laboratory animals. "This means that the applications cover 80 and possibly more species," says GE Free in its statement of claim. It also says there is an absence of information required by the HSNO Act. And that information provided is so limited or generic that it means the public are unable

to consider "whether or how they might be affected by the applications or make meaningful submissions in opposition or to propose conditions". GE Free is particularly concerned that "the gene sequences derived from animals, micro-organisms, viruses, plants or synthetic sequences and nucleic acids" are not specifically identified.

It's not the first time AgResearch has faced legal challenges. In 2003, Mothers Against Genetic Engineering (MaDGE) lost a court bid to stop an AgResearch application for the "outdoor" development of GM cattle and was ordered to pay $24,000 in court costs.

"Any delays are problematic for the research because we are competing with scientists around the world and it creates great uncertainty for
commercial applications," says Laible.

The Crown Research Institute also came under fire earlier this year from the Green Party which questioned explanations about a less than 9 per cent live birth rate in AgResearch's transgenic cattle. The Greens raised animal welfare concerns about "aborted deformed foetuses, deformed calves, gangrenous udders and 'animals suffering from respiratory conditions"'.

Laible says the company regularly faces inquiries via the official information act about its work. "Part of this is a misconception of what we are doing and that we are hiding something which is not the case." He says the complexities of the nuclear transfer (cloning) process is the reason why the efficiencies to generate animals have not been very high. "These problems don't originate from the different gene constructs we put, it is related more to the technology used to produce the animal."

Laible says the institute has always been open about what it's doing and allowed the media to visit and photograph its animals. Ironically, photographs of AgResearch's transgenic cows - which look the same as non-GM cows - are often used by media organisations as generic photos to illustrate stories about the dairy industry.

Laible says Biotherapeutics facility for its goat herd in the United States illustrates how the issue of risk with GM animals gets turned on its head. Typically, the overiding concern in GM field trials is containment - putting in place controls to ensure no genetic material escapes into the environment.

But when pharmaceuticals are involved, the principle concern is to make sure nothing gets in to contaminate the product. As such, transgenic herds must be kept

in highly secure environments with stringent controls to ensure the animals and their milk don't come into contact with infectious agents.

GE Free's legal action prevents Laible from commenting about AgResearch's current Erma application. But he points out GM science is moving so fast that it's important to have the freedom to use the latest GM tools and knowledge rather than re-invent the wheel - hence the need to be able to import and use GM products across a wide range of animals.

"What I find frustrating is that the issues haven't changed since our first animal trial approval," he says. "Essentially we are talking about the same scope, the same methodology, the same purposes.

"It's maybe slightly broader, but the risks are still pretty much the same. We have a good record and no problem with any escapes, but the process [of approval] doesn't get any faster. Why does it take so long when the issues are known?"

Back at the Biosafety Symposium, Claire Bleakley of GE Free NZ asks a question at the public forum: "The public is looking at what a transgene does. It is stitched together with viral, microbial and antibiotic elements. So we are creating a synthetic chromosome. The concern of the public is what it will do in an often foreign environment - whether it will jump, whether it will fragment in how it's put in, and how it will work with the diversity of nature.

"What is occurring in GM is we are getting a smaller and smaller pool of genetic diversity. We are breeding out what nature has bred in ... Species have their own integrity and we are breaching that by putting human genes into animals. Can you tell me how you address that risk?"

The question is answered by the Symposium programme chair, Jeremy Sweet, who has 17 years experience in risk assessment of genetically modified organisms and has been an advisor to the European Commission, Danish Parliament, and British government on the subject.

He says studies on a range of crop varieties show the opposite of what Bleakley is saying and that new genetic technologies are actually enabling the preservation of primitive varieties of crops.

"The argument that we are depleting genetic diversity in the sort of work we are doing is rubbish. We are actually creating and utilising more genetic diversity."

- NZ Herald

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