Erma confirms approval of human-gene cow research

12.00pm

New Zealand's new organisms watchdog today approved a bid by crown science company AgResearch to develop in containment a range of genetically engineered cattle and transgenic milks -- some containing human proteins.

The Environmental Risk Management Authority (Erma) gave its permission only after cutting back the wide-ranging scope of the "development" application, and limiting it to 7-1/2 years instead of the 10 years sought by Agresearch.

A special committee of Erma, headed by chairwoman Jill White, said though AgResearch was free to make a generic application "the range of possible genetically modified organisms encompassed by the application introduced too great a level of uncertainty to enable risks, costs, and benefits to be confidently weighed.

"The scope of the organism description was accordingly reduced and additional controls imposed, to reduce the level of uncertainty," the committee said in its decision, released today.

AgResearch had sought approval for a wide range of development work, including generation of transgenic cattle, and breeding the most promising animals to check which genes had "stuck" and the traits they convey.

In effect, it wanted a 10-year licence to develop GM cattle producing working human proteins in their milk, potentially of use in medical treatments, and to study how individual genes function in the animals.

AgResearch attracted criticism for framing its project very generally. Their application said they wished "to develop transgenic cattle that can express functional therapeutic foreign proteins in their milk, and to develop transgenic cattle to study gene function and genetic performance".

It wanted to be able to put copies of cattle, sheep, goat, deer, mice, and human genes into cattle, but on a "project" rather than single organism basis to give it flexibility to change the experimental work as it produced results.

AgResearch said this would mean successful avenues of research could be followed up without requiring a new regulatory approval.

The development work would largely be in laboratories but eventually some calves would need to be kept in a highly regulated containment farm with outdoor pastures.

"Successful expression of transgenes may lead to a field test application to expand the herd to test performance," AgResearch said.

"We will likely mate animals to check gene stability and so some reproduction is likely to occur as part of the development programme ... especially in the case of gene knock-outs".

Development of the GM cattle will span three or four years. The GM animals will be created in the first year and raised over the next three years while scientists analyse which genes and traits they have acquired, and whether they can retain those in the breeding of further generations of animals.

But some among the 850 people who objected to the application said the reproduction and milking of transgenic animals represented a "field test" rather than development.

"It is essential to set boundaries on this development application to ensure that it does not include field testing," the committee said in its decision.

The Erma committee said there should be no breeding of animals engineered simply to study gene function and genetic performance, unless the research needed homozygous animals -- possessing two identical forms of a particular gene, one inherited from each parent.

But cows modified to produce therapeutic proteins in their milk could be bred if necessary to investigate the stability of the engineered gene through more than one generation.

The committee said it had sufficient information to validly consider the generic application but "the generality and breadth of the organism description leads to a significant uncertainty as to the magnitude and likelihood of the adverse effects".

So it had decided to restrict the scope of the "approved organism" and add further controls, by:

* restricting the use of bacteria and viruses, to reduce the potential for altered genes to be transferred "horizontally' to other organisms;

* excluding known human and viral cell receptors to reduce the likelihood of GE cattle becoming new reservoirs for human or animal viral diseases;

* requiring the scientists to only insert genes for which they know the function, to reduce the chance of "unintended effects";

* restricting the use of marker genes to ones which do not create resistance to antibiotics, or give micro-organisms advantages which could allow them to spread more easily in the environment;

* excluding all material that could potentially cause prion diseases such as bovine spongiform encephalopathy (BSE) -- mad cow disease. Some prion diseases, such as creutzfeldt jakob disease (CJD), are fatal in humans.

The committee said many submissions on the application raised concerns about unintended effects, including those arising from horizontal gene transfer to organisms beyond cattle, such as soil bacteria, unknown allergens and toxins, development of new viral diseases, and introduction of viral receptors with mammalian genes.

Possible effects on other organisms which came into contact with the cattle, including blood-feeding insects such as mosquitoes, could not be excluded.

It also said there were two opposing lines of ethical opinion over the application. One said the research should go ahead because it could lead to improved human health without harming the environment, and the other said it was ethically wrong to transfer genes between species.

It canvassed the significance of four specific issues raised: that genetically engineering companion animals was unethical, that genetic engineering was against the teachings of the Bible, animal welfare issues, and concerns about entry of cattle products containing human genes into the food chain.

The committee said the Royal Commission on Genetic Modification had only expressed a preference when it said: "It would seem preferable to give priority to using animals not usually used for food as bio-reactors in order to lessen the possibility of human health impacts and the associated anxiety over the potential for affecting food sources."

Ethical risks were not negligible, but did not over-ride the application.

On economic risks, the committee said it was not its job to consider the adequacy of the legal framework for attributing liabilities that might arise from genetic engineering.

The panel said the research was "very likely" to bring increased scientific knowledge and skills, and may enhance New Zealand's reputation in the scientific world.

But there was "considerable uncertainty" in assessing the magnitude of the benefits of the research, which it said would range between minimal and moderate, depending on the research success.

If the application were rejected, it could lead to potential loss of scientists and expertise, and deter business investment in biotechnology -- but it said such benefits had been given minimum weighting.

The potentially significant risks of the amended application were negligible, including risk to public health from antibiotic resistance and human consumption of meat or milk from the GE experiments, and biological and physical risks to the environment and human health from escape of GE cattle.

The issue was whether the benefits of the cut-back application outweighed risks and costs which were more than negligible -- environmental risks outside the ability of the cattle to escape, risks to animal welfare, and Maori cultural and spiritual concerns

"The benefits do outweigh these costs and risks, although this is very much a matter of judgement," the committee said.

- NZPA

Full text of the Erma decision

Human-gene cow research tipped for Government approval

Further reading
nzherald.co.nz/ge

GE links

GE glossary