- Link to Canola Decision [pdf - 15 kb].
- Canola Background
- Canola Reassessment
- Canola Application Register Information
- GM Canola: Queston and Answer Sheet.
Canola Background
GM canola field tests were undertaken in the early 1990s at Dromore, St Andrews and Lincoln in Canterbury and Pukeuri in North Otago. All the trials were completed in 1997/98. They were approved by the Minister for the Environment, under a voluntary regime before the HSNO Act came into effect. The approvals required the sites to be monitored after the crops were harvested, in case any further canola plants appeared.
The Authority wanted to satisfy itself that the sites were being monitored long enough, given that canola seeds can last in the ground for up to 10 years It has decided that the original monitoring period might need to be extended. [This was set at 4 years, or one year after the last canola seeding appeared on the site].
The Chief Executive of ERMA New Zealand has decided to approach the companies concerned to carry on monitoring the sites, rather than going back to the Authority for a formal Re Assessment.
"This is the most cost effective way to deal with the issue. The companies will be formally requested to undertake further post harvest monitoring and to remove and destroy any plants that appear. We will ask MAF to monitor and inspect the sites."
Dr Walker said that the decision not to proceed with a formal Re Assessment application at this stage did not prevent other parties from doing so. However, where the Chief Executive of ERMA New Zealand is the applicant, the costs are borne by ERMA New Zealand.
Dr. Walker noted that this decision has no bearing on a potential application from Monsanto for the release GM canola. "These were field tests and they are now completed. The possible Monsanto application which has not been received would be for the release of GM canola. Under the HSNO Act a GMO release (as opposed to a field test) is a full release. The Authority is not able to put conditions on how or where the organism is grown i.e. no controls can be set."
For further information:
|
Dr Bas Walker, |
Karen Cronin, |
GM Canola: Queston and Answer Sheet
Why has the Authority decided there are Grounds for a Re Assessment?
A series of GM canola field tests were undertaken in the early 90's and completed in 1997/98.
The crops were tested at 4 sites: Dromore, St Andrews and Lincoln in Canterbury and Pukeuri in North Otago. The original approvals included a requirement that the sites be monitored after the crops were harvested, in case any further canola plants appeared. The question arose as to whether the sites were being monitored long enough, given that canola seeds can last in the ground for up to 10 years.
The Authority wanted to satisfy itself that there is adequate post harvest monitoring on these sites. It has decided that the original conditions (which required monitoring for 4 years or one year after the last canola seedling appeared), may be inadequate and might need to be reconsidered.
What happens now?
The Chief Executive of ERMA New Zealand has the option of making a formal application to the Authority for a Re Assessment. Under the HSNO Act, anyone can apply to have a Re Assessment done but if the Chief Executive makes it the costs are borne by ERMA New Zealand.
In this case, the CEO has decided that a full Re Assessment process may be unnecessary. The field tests themselves are over and the sites are no longer being used for GM crops. The only concern is related to a variation on one of the conditions i.e. to extend the original post harvest-monitoring period. It would be satisfactory for the companies to undertake this on a voluntary basis.
What happens if they don't agree?
It is expected that this approach will be the most effective for the companies involved and will meet the requirements of the Authority that adequate monitoring is done. The Chief Executive still retains the option of proceeding to a full Re Assessment at any time in the future.
Who will be monitoring the sites to make sure the companies comply?
Monitoring and enforcement is the responsibility of MAF. ERMA New Zealand will be asking MAF to establish an appropriate monitoring regime for these sites, including inspection and verification.
If this is a only a voluntary requirement for the companies, what real enforcement controls will exist?
This approach is seen as being the most effective in the circumstances. There is always the potential to invoke the statutory process which would lead to formal controls.
Weren't there some reports of problems at these sites – and if so did the Authority investigate these issues?
The field test of GM crops on these sites is now completed. The focus of the Authority was to ensure adequate post harvest monitoring into the future.
What implications does this have for the Monsanto canola application?
There are no direct implications. These were field tests and they are now completed. The possible Monsanto application – which has not been received – would be for the release of GM canola. Under the HSNO Act a GMO release (as opposed to a field test) is a full release. The Authority is not able to put conditions on how or where the organism is grown i.e. no controls can be set.
Ends
For further information:
|
Dr Bas Walker, |
Karen Cronin, |
Control on taste testing of genetically modified salmon
ERMA New Zealand Background Note:
23 February 2000
The Environmental Risk Management Authority has today announced its decision on the reassessment of the genetically modified salmon development by the New Zealand King Salmon Company Limited (NZKSCL) at its research facility at Kaituna near Blenheim. The Authority has specified a control on the consumption of salmon from the site as part of the development programme, as below:
Control 1.15 - At no time shall the genetically modified Chinook salmon either be offered or made available for human or animal consumption unless the consumption is for test purposes, is within the containment facility and in the case of human consumption, with the informed consent of those involved. The company must submit a tasting proposal, to the written satisfaction of the Authority, before any such testing is undertaken.
It noted that human consumption in particular may require an approval from authorities other than the Environmental Risk Management Authority. The NZKSCL has indicated that in future it may use taste testing to consider the acceptability of different lines of GM salmon. The Authority wished to cover the possibility that such tests would fall outside the scope of the Australia New Zealand Food Authority (ANZFA) and would therefore be unregulated.
What legislation covers taste testing of genetically modified organisms?
In ERMA New Zealand's view, it appears no approval from ANZFA is necessary for the taste testing of GM salmon, under the ANZFA Standards (and its governing legislation the Food Act). This is because the salmon are not being sold, even under broad definition of ?sale? contained in the Food Act. However this is a complex legal issue, and interpretations by other agencies may show a different result.
ERMA New Zealand also believes that taste testing appears to contravene the spirit, though probably not the letter, of the HSNO Act. Much depends on how broad a view is taken of the requirements to "contain" organisms, and the use of controls under the Act. Without a control there would be nothing to prevent taste testing of the GM salmon from this development programme. The Authority has added the control to ensure the any such activity can be managed, rather than fall in the cracks between different legislation.
Unique situation
This GM salmon development programme is unique in comparison to other development approvals under the HSNO Act. All other approvals have controls that require either Physical Containment Level 1 (PC1) or 2 (PC2) to be met at all stages of development. These containment levels are detailed in the Australian/New Zealand Standard AS/NZS 2243.3:1995 Safety in Laboratories: Part 3: (Microbiology) and require that no food can be consumed in the laboratory. So although there are no specific requirements related to taste testing it is excluded for laboratory safety reasons.
The NZKSCL programme involves a PC1 approved laboratory and hatchery facility. It uses contained outdoor raceways where the growth and development of different lines of salmon are monitored up until maturity (when the salmon are harvested for eggs and sperm and then killed).
Not all the work for this development is subject to PC1 containment controls. Taste testing is therefore a potential activity that was not specifically prevented by the previous voluntary controls. However no such testing has yet been performed by the company.
What about other GMO development work and field tests involving edible crops and animals?
GMO research and development applications can be approved under delegation by Institutional Biological Safety Committees (IBSCs). There is limited potential to apply controls on taste testing because strict laboratory containment conditions cover such work.
All the field tests approved to date by the Authority have been for the evaluation of varieties or seed increases for further experimental work or for the manufacture of biopharmaceuticals (eg. PPL sheep). These approvals have controls that either prevent taste testing explicitly (as in the case of the Pioneer Maize applications GMF98006 and GMF98006) or require all material to be disposed of by a certain method. Where the controls are not explicit, there may be room for doubt.
ERMA New Zealand is therefore writing to all holders of development and field test approvals to: ? explain the taste-testing controls on the salmon programme "to restate the controls that prevent taste tests under their own existing approvals, and" to make it clear that the conditions for the salmon apply to all GMO approvals. The full text of the GM salmon reassessment decision is available on the ERMA New Zealand website at www.ermanz.govt.nz.
Salmon Background
Research at New Zealand King Salmon's Kaituna hatchery has been going on since May 1994. The project was approved by the Minister for the Environment under a voluntary regime, on the recommendation of the Advisory Committee on Novel Genetic Techniques.
ERMA New Zealand Chief Executive, Dr Bas Walker, says that the company has been conducting a legal operation since that time and has complied with the conditions that were originally set.
However, the voluntary system was replaced by statutory controls in 1998, when the Hazardous Substances and New Organisms Act 1996 came into effect. ERMA New Zealand has since been checking that all previous approvals have conditions consistent with HSNO requirements.
"In the case of this facility, it appeared that there could be an issue about the adequacy of the controls put on the original approval. The Authority had to consider if there were Grounds for proceeding with a formal Re Assessment. It has decided that it would be worth taking a closer look, to ensure that the controls are appropriate in HSNO terms and that any risks are adequately contained."
Under the Hazardous Substances and New Organisms Act 1996, it is now up to the Chief Executive of ERMA New Zealand to proceed with the next step in the process. Dr Walker said that he would be applying to the Authority to undertake the Re Assessment in a few weeks time.
"The Re Assessment application will focus on technical issues related to the adequacy of the containment controls. It will not be a full-scale review of the project itself. My concern is to ensure that the potential risks are being effectively managed – and that appropriate containment procedures are in place."
It would probably take a further 6 - 8 weeks for the Authority to go through the formal Re Assessment process. The Authority has decided that the salmon research has the status of a ‘development' project and that it should not be publicly notified. The reason is that the Grounds for Re Assessment relate only to the controls on the site, not to the approval itself.
However, the final Decision will be made public through the ERMA New Zealand's monthly Bulletin.
For further information:
|
Dr. Bas Walker, |
Karen Cronin, |
GM Salmon: Question and Answer sheet.
Why has the Authority decided there are Grounds for a Re Assessment?
ERMA New Zealand has done a review of all the old ACNGT and IAG approvals, which were transferred to the HSNO Act when came into effect last July. The aim was to check if the controls on these approvals match up in terms of HSNO requirements. The Authority decided it was worth taking a closer look at the containment controls for the salmon operation. There are grounds for proceeding because there is a question about whether the controls are adequate, in HSNO terms.
Given all the public concern, why is no action being taken against the company?
The company has done nothing wrong. It has complied with its legal obligations and the controls as set down by the previous approval agency, the ACNGT.
What are the containment risks in this situation?
The issue is to ensure that there is no loss of GM material from the facility. For example, salmon eggs or sperm getting through the netting in the raceways. Issues have also been raised about the disposal of dead salmon off site.
Has ERMA New Zealand been down to inspect this facility?
An informal visit was made by ERMA New Zealand staff late last year, as part of the general review of transferred approvals. Formal inspection and monitoring is the responsibility of MAF, under the BioSecurity Act. MAF inspections have indicated that there are no issues in terms of compliance with the existing controls.
What is ERMA New Zealand doing about the reports of deformities in the salmon?
This is not an issue in HSNO terms, so long as the organism is properly contained. Any potential issues related to the general welfare of organisms used in GM research are covered by other legislation administered by MAF.
Why is ERMA New Zealand not taking any action on the reports of dead salmon being dumped at the local tip or at sea?
The information the Authority has received indicates that there never has been any dumping at sea of GM salmon from this facility. There was some disposal at the local tip but the company explicity sought approval for this action from the ACNGT and permission was granted.
What happens now?
The CEO of ERMA New Zealand has decided to make a formal application to the Authority to do a Re Assessment. Under the HSNO Act, the Authority has to consider the Re Assessment application as it would any other application. Preparing the ‘application' itself will take about 3 weeks.
What will the Re Assessment application cover?
The Re Assessment application will be aimed at ensuring that the controls are appropriate to the work being done and that they adequately contain all the risks. If the old controls do not adequately contain the risks, they may be varied. The focus will be on the technical issues related to the controls, not a full-scale review of the project itself.
Will this be notified and will the public be able to make comments?
Under the HSNO Act, ‘development' applications do not have to be notified - see S.53 (2) – and therefore there is no provision for a public submission process. However, the Authority does have the discretion to notify the development of a GMO in containment if it considers there is likely to be significant public interest.
The Authority has decided that the New Zealand King Salmon project is GM ‘development' work, rather than a GM ‘field test'. This project, where salmon are being kept in a contained raceway, is seen as comparable to research done on GM plants in a contained greenhouse.
It has decided that formal public notification is not warranted because the issues for the Grounds decision are purely technical i.e. whether the controls need to be adjusted. There is no intention to review the approval itself.
The process is public to the extent that the Authority is issuing its Decision to the media and putting it in the Bulletin and the ERMA New Zealand website. The final decision, once the Re Assessment process itself is completed, will also be made public through these channels.
For further information:
|
Dr. Bas Walker, |
Karen Cronin, |
or email to: info@ermanz.govt.