Erma formally notifies Agresearch development bid for GE milk

4.00pm

The Environmental Risk Management Authority (Erma) has formally notified Agresearch's re-jigged application to develop in containment a range of genetically engineered cattle, and transgenic milk containing human proteins.

The application is a substitute for an earlier one withdrawn on April 11, which only sought approval for parts of the project.

Other stages of research, for which Agresearch is effectively able to give itself permission through an institutional biological safety committee (IBSC) have been incorporated in the new application. Many research facilities have an IBSC with delegated authority from Erma to make decisions on low-risk genetic engineering applications, often ones fully contained in a laboratory.

The latest application is notable for canvassing a wide range of development work. It included generation of the gene constructs, through implantation of modified embryos in recipient cows to produce transgenic calves, to the development of lines of GE cattle to check gene stability and to characterise gene expression.

Agresearch wanted to develop GE cattle that could produce working human proteins in their milk, which could potentially be of use in medical treatments, and to develop GE cattle to study how specific genes function.

The Agresearch application appears to be an extension of work for which it successfully sought approval at a public hearing in August 1999, when it won permission for three specific pieces of genetic engineering.

Two related to adding or deleting cow genes to change the composition of cows' milk for food production, and the third involved the controversial insertion of a human protein called myelin basic protein. That research was cutting-edge and promoted by Agresearch as a world first, but it faced strong opposition from some critics of the technology, particularly over the use of human genetic sequences in cows.

Scientists predicted those trials would take five years and it would be at least 10 years before the project could become commercial.

In the latest application, Agresearch has framed its project in much wider terms, "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 now wants to be able to put copies of cattle, sheep, goat, deer, mice, and human genes into cattle, but is not applying for field tests.

So this time it has told Erma the application is on a "project" rather than single organism basis. This, it said in a summary of its application, would give it flexibility to change the experimental work as it produces results, so that successful avenues of research can 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 transgene may lead to a field test application to expand the herd to test performance," Agresearch said.

The animals were not planned for use in normal commercial reproduction.

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

No transgenic cattle or their products would enter the human food chain.

"The risks have been assessed as low and the track record of the containment facility indicates that the likelihood of escape is very low".

Erma is seeking public submissions until June 27.

- NZPA

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