NZ's transgenic sheep face slaughter

Whether it refers to cause or consequence, the term 'overkill' applies: New Zealand biotechnology company PPL Therapeutics is being forced to slaughter its unique flock of 3500 transgenic sheep in the name of public safety.

The sheep are genetically modified to secrete a recombinant version of the blood protein -1 antitrypsin in their milk, as a potentially life-saving treatment for cystic fibrosis, hereditary emphysema and chronic obstructive pulmonary disease.

Only 500 of the sheep remain alive -- mainly ewes and lambs. The rest have already been shot and incinerated, in compliance with the regulatory requirements New Zealand's GM regulator, the Environment Regulation and Management Authority (ERMA)

"It's just an unfortunate set of circumstances," said Dr Jim Watson, CEO of Genesis Research, commercial arm of the AgResearch Crown Research Institute. "We had the Royal Commission, and as a result, our policies and regulatory processes became more stringent.

"I don't think anyone thought about the likelihood of having a company owning a flock of more than 3000 transgenic sheep go into liquidation, and being required to slaughter them."

Bayer Biological Products contracted PPL Therapeutics to raise up to 5000 of the transgenic sheep on a specially designated bio-secure farm, in an experiment project to test the feasibility of producing the therapeutic protein commercially in sheep's milk.

PPL received permission from ERMA to proceed in 1998, several years before the New Zealand Royal Commission on GMOs, which recommended that research and development continue, but under more stringent regulations.

Bayer Biological Products' strategic decision late last year to terminate the project caused the financial collapse of PPL Therapeutics.

It also activated ERMA's original edict requiring the slaughter and incineration of all biological materials associated with the project, meaning that all tissues, transgenic embryos and semen must be destroyed as well.

While Bayers's decision removed the original reason for the project, Watson said the large, multi-generational transgenic flock represented a unique opportunity or researchers to monitor the long-term effects of gene transfer on a large mammal.

Such research would have been invaluable to New Zealand's biotechnology industry, whose future will be heavily dependent on developing transgenic sheep, cattle as bioreactors to produce therapeutic proteins for human medical use.

At the time Bayer announced its decision, Genesis expressed an interest in maintaining the farm for its own, future field experiments. But that opportunity now appears to be forfeit -- Watson said he feared that with the slaughter of the sheep, the farm would lose its bio-secure status and revert to normal use. "Once large transgenic animals have been on the land, there is a requirement to do environmental surveys to certify it is now safe for use by normal livestock," he said.

Asked whether the government could intervene to prevent the completion of the slaughter, Watson said he doubted it would do so, in the current climate of community anti-GM sentiment in New Zealand: "The regulations are so stringent that it would be difficult without a lot of planning to justify the use of the animals for something else. Another transgenic livestock project would take a long time to develop and gain approval.

"There's no easy way to get the funding needed to analyse the sheep's tissues, and no quick way of getting around the red tape -- they're doomed."

The only positive to emerge from the episode, said Watson, was that scientists and regulators had been alerted to the possibility of such problems occurring again.

Former New Zealand Prime Minister Jim Bolger, who is now the chairman of New Zealand's newly formed BioScience Policy Institute, said a failure to consider the strategic value of ERMA's approval to create the transgenic flock meant that New Zealand's research community was on the verge of losing a resource of significant scientific value.

Bolger said the BioScience Policy Institute had consulted with NZ and overseas scientists, and concluded that the lack of a control group of sheep for comparative purposes, and lack of funding to maintain the transgenic flock, meant there was no compelling reason not to allow the remainder to be disposed of.