March 23, 1999
To access application details go to the Register.
The Environmental Risk Management Authority has publicly announced its
decision on the application from PPL Therapeutics Ltd. to field test a
flock of genetically modified sheep.
A background note on the PPL Application is attached.
The application was to field test (maintain a manufacturing ewe flock) of transgenic sheep in containment, in order to produce commercial quantities of the protein human alpha-1-antitrypson (hAAT). The protein is expressed in the milk of the transgenic ewes.
The Authority has approved the application with controls. It concluded that the adverse effects were outweighed by the beneficial effects, taking into account the scope for risk management. It was satisfied that the proposed containment regime, together with additional controls it has imposed, would adequately contain the organism. The controls include:
- Keeping the sheep in MAF approved containment facilities.
- Disposal of all waste milk and cream on site and disposal of all sheep and any biological. material derived from the sheep on site or by incineration.
- Excluding unauthorised personnel from the containment facility.
- Excluding other organisms from the containment facility.
- Electronic monitoring of the perimeter fence.
- Individual tagging of sheep and implanting microchips for identification.
The company is required to provide an annual report to ERMA New Zealand on compliance with the controls. The monitoring and enforcement of the controls is the responsibility of MAF, under the Bio Security Act.
The application was considered by the Authority at a public hearing in December 1998. The Authority received thirty submissions in response to the proposal.
The Environmental Risk Management Authority is a semi judicial body appointed by the Minister for the Environment under the Hazardous Substances and New Organisms Act 1996. It comprises eight members with a range of expertise, including scientific expertise in the areas of hazardous substances and new organisms.
For further information contact:
| Dr. Bas Walker Chief Executive ERMA New Zealand Ph. 04 473 8426 |
Karen Cronin Communications Manager ERMA New Zealand Ph. 04 496 4826 or 04 386 2359 or 04 918 4826 |
Other documents available from ERMA New Zealand.
- Full Authority Decision on PPL application
- Application from PPL New Zealand Ltd.
- ERMA New Zealand Evaluation and Review Report
- Note on PPL Hearing/ Committee
- Nga Kaihautu Tikanga Taiao members/Report on PPL
- Info sheets on GMOs, GMFood,
- Guides on: ERMA New Zealand people and structure, the application process, hearings etc.
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Background note on the PPL Application
Embargoed until Tuesday 23 March 1999 11am.
PPL aims to produce a biopharmaceutical from sheep's milk for the treatment of cystic fibrosis.
The process involves putting a copy of a human gene into the sheep, to generate a special protein in the sheep's milk. The milk is then processed to extract the biopharmaceutical product. The sheep are being used to create sufficient quantities for commercial production of the product, should it prove successful in clinical trials.
PPL Therapeutics Ltd. is a Scottish company, which specialises in producing biopharmaceuticals. It is famous for developing the first clone of an animal in the world, known as Dolly the Sheep.
[Cloning involves taking a body cell from an animal and making a carbon copy of the animal. This kind of work has been done for years with plants e.g. by taking a cutting and growing up a new plant. It is now being done with animals. However, cloning is not being used in this case.]
PPL New Zealand Ltd. is working with George Mitchell Partnership in the Waikato to develop a manufacturing flock of transgenic ewes. PPL is conducting clinical trials overseas for its biopharmaceutical products.
People with cystic fibrosis (CF) have an excess amount of a substance called ‘elastase', which damages their lungs. This is reduced by a protein called human alpha-1-antitrypson or hAAT. Illness and death from CF primarily results from chronic lung infection. However there are also effects on digestion. The symptoms are currently managed with a range of treatments; but there is no known cure for cystic fibrosis
Up until now, a limited supply of hAAT from human blood donors has been available in some countries for people with congenital deficiency of AAT but not CF. The hAAT derived from human blood has a potential risk of blood borne disease.
PPL has found a way of producing hAAT using sheep. They have taken the gene for hAAT from a healthy person - and copied it. This copied gene was then successfully inserted into a sheep embryo in Scotland in the early 1990s.
In 1992, a number of New Zealand sheep, which had the advantage of being free from scrapie, were taken to Scotland and bred with this gene inserted. Semen taken from a transgenic ram in this flock was imported back into New Zealand in 1996. This import was subject to a risk assessment and approval by MAF.
A small flock of about 100 sheep was then developed by PPL New Zealand Ltd. using this semen. The Minister for the Environment approved this development of New Zealand transgenic rams in May 1996, based on the recommendation of the Interim Assessment Group. The IAG was the body that assessed GMO field trial applications in New Zealand before ERMA New Zealand was set up.
The next stage of the process is to breed a manufacturing flock of ewes, which will express the hAAT protein in their milk. This is the step which has now been approved by the Environmental Risk Management Authority.
The Authority's approval has been made under the Hazardous Substances and New Organisms Act 1996. It is for a GMO in containment. This means that the sheep are kept under strict surveillance conditions. The sheep are not for human consumption. All the by products of the sheep [not including wool] are to be disposed of on site and the sheep are also to be disposed of on site.
The main interest of the company is to extract the protein from the ewes' milk. Two flocks of up to 5000 ewes have been approved. If clinical trials of the product are successful, PPL will then seek to register it e.g. in the US and UK. A manufacturing plant may then be set up in New Zealand to process the milk.
If the biopharmaceutical product is commercially developed, it might be available in New Zealand in future, but this would require the approval of the Ministry of Health. The subsidised supply of the drug in New Zealand would also require approval from PHARMAC.