April 26, 1999
Background
Before the Hazardous Substances and New Organisms Act 1996 came into effect for new organisms in July 1998, there was an informal system for assessing GMOs in New Zealand.
The development of GMOs was considered by the Advisory Committee on Novel Genetic Techniques (ACNGT). This covered GMOs developed in a laboratory setting, primarily for research purposes. Field testing of GMOs - in which the organism could be bred outdoors in containment - was considered by the Interim Assessment Group (IAG). The IAG provided recommendations to the Minister for the Environment who made the final decisions.
Approval from the ACNGT or the IAG was compulsory for government agencies but voluntary for private companies. In effect this system provided advice on 'best practice' for safely managing and containing GMOs - but there was no statutory basis for the decision or powers of enforcement.
When the HSNO Act came into effect, 178 ACNGT approvals and 23 IAG approvals were transferred and deemed to be HSNO approvals. Since last year ERMA New Zealand has been systematically reviewing all the prior approvals, to check if they match up in terms of the requirements of the Act.
To date, two approvals appear to require further investigation - for salmon and canola.
The Reassessment Process under HSNO
Any person, or the Chief Executive of the Authority, may at any time request the Authority to decide if there are Grounds for Reassessing any new organism in containment. Note: there is no provision for reassessing a new organism which has previously been approved for release.
Under S.62 of the HSNO Act, the Authority can reassess an organism in containment if: - significant new information relating to the effects of the organism has become available; - information showing a significant change of use, or a significant change in the quantity, imported or developed has become available.
The process has five steps:
1. The CEO or any person considers there may be Grounds for Reassessment and makes a 'request' (application) for it. 2. The application is put to the Authority. If it has come from the CEO it is put directly to the Authority. If the request is generated externally, it is accompanied by a staff report. 3. The Authority, or a committee of the Authority, decides if there are Grounds for Reassessment. 4. If Grounds are established, the Chief Executive or any person may then ask that the Reassessment proceeds. The Reassessment only goes ahead if this second request is made. 5. The Re Assessment then becomes a normal Part V Application. It is processed using the same criteria as other new organism application under the HSNO Act.
Following Reassessment, no compensation is payable to any person for any loss where the Authority declines to approve the release of any new organism from containment or declines to approve any further importation, field testing, or development of any new organism in containment. The Authority may further direct the owner of the organism to dispose of it at the owner's expense.
Reassessment of Salmon- Questions and Answers 26 April 1999
1. Why is the salmon approval being reviewed? The salmon approval was reviewed along with all the other 177 ACNGT approvals, in a process which has been going on since last year. This review has not been prompted by recent media attention. ERMA New Zealand has been doing this review because all the transferred approvals need to match up to the requirements of the HSNO Act. In HSNO terms, it appeared that aspects of the salmon work were more in the nature of a field test than a GMO development, as originally approved. The conditions set at the time may not entirely meet the criteria of the Act.
2. What kind of issues will be taken into account? If the Authority decides there are Grounds for a Reassessment and it goes ahead, it is possible for people to bring forward information to the process. However, for it to be taken into account by the Authority, the information needs to be relevant to the criteria set down in the Act. Other issues which have been raised recently may be taken into account if they are relevant e.g. to the effects of the organism on the environment and public health, or in relation to the containment requirements.
3. Is anyone taking action now on the New Zealand King Salmon operation? The salmon work was approved by the ACNGT with conditions, as set out in Schedule 9 of the Government Gazette of July 1998. At this point, ERMA New Zealand has no information that any of the previous conditions have been breached. However, all prior ACNGT approvals are being monitored by MAF for compliance with conditions. MAF is due to report on its monitoring work shortly. If any breaches of conditions are found, MAF may take action. The MAF reports will be taken into account by the Committee considering Grounds for Reassessment.
4. What are the criteria for deciding that there are Grounds for a Reassessment? Under S.62 the HSNO Act, Grounds for reassessing the approval for an organism in containment include: - significant new information relating to the effects of the organism has become available; - information showing a significant change of use, or a significant change in the quantity imported or developed has become available. The decision will be made following a report from ERMA New Zealand staff, which incorporates the results of its review of the old ACNGT approval.
5. Is the ERMA New Zealand staff report on Grounds for Reassessment publicly available? The report will be provided to the company and will be made available to others on request.
6. How else can the public get information on this issue? The New Zealand Gazette No. 101 [July 1998] includes information on the original ACNGT approval and the conditions that were applied. The MAF monitoring reports are available on request from MAF. The ERMA New Zealand website carries information on all the prior approvals and the reassessment process.
7. Will the Authority meeting that considers the Grounds for Reassessment be open to the public? The decision on whether there are Grounds will be made by the Authority or a Committee of the Authority, on the basis of the ERMA New Zealand report. It is not a public hearing. This step of the process does not require a submission by the company or any other party. However, the Authority may seek further information in order to make its decision and this would be provided through ERMA New Zealand staff. In the case of salmon, the company has been invited to comment on the 'application'.
8. Who are the Authority members making these decisions? The Grounds for Reassessment is likely to be considered by the Authority's standing Committee on GMOs. It includes: Dr. Barry Scott[chair], Dr. Oliver Sutherland, Mr. Bill Falconer, Mrs. Helen Hughes and Dr. Colin Mantell.
9. Can anyone appeal the decision to establish Grounds? There is no appeal on the initial decision on "Grounds". However, the outcome of any reassessment can be appealed on questions of law.
10. What is the time frame for deciding if there are Grounds for Reassessment of the salmon? There is no statutory timeframe set down in the Act. However, it is expected that the staff report to the Authority will be presented in the week of 26 April 1999. The GMO committee is expected to meet in mid May. A decision on whether or not there are Grounds could be expected in a further 3-4 weeks.
11. What happens after that? If Grounds are established, an application would then have to be made for the Reassessment itself. This would include a determination of whether the Reassessment would be for a GMO in development or GMO field trial. If it is a GMO development, the Authority is not required to notify it. But it could decide that there was sufficient public interest to warrant a public notice. A field test application would automatically be notified. Notification involves placing a formal Public Notice in the newspapers.
12. What is the timeframe for the Reassessment itself. The Reassessment process would follow the normal application process. The application would be put on the Authority's Register and this is viewable on the website at www.ermanz.govt.nz. For a field test, the total process could take a minimum of 80 days, including a 30 day period for public submissions. For a non-notified development application, the process would take a minimum of 40 days.
13. What happens to the salmon in the meantime? Assuming no separate action is taken by MAF, the current approval will remain - unless it is altered or revoked. The New Zealand King Salmon Operation would therefore continue under its present conditions.
14. What are the criteria for doing the Reassessment? The same as for any other GMO in containment application under S.45 of the HSNO Act.
15. Who would consider and decide on the Reassessment? Either the full Authority or the GMO Committee of the Authority. They may co opt additional expert members, depending on the nature of the application and the issues involved.
16. How can local people and the wider public have a say? If the Reassessment is non notified, there is no opportunity under the Act for public submissions. If the Reassessment is publicly notified, submissions would be sought. Any person making a submission is able to request a hearing. The hearing would probably be held in Wellington and would be public. General information about the process would also be available in the Authority's official Bulletin, issued monthly; and on the website at www.ermanz.govt.nz In addition, ERMA New Zealand also directly advises people on its Application Interest List when applications are received, including Reassessments.
17. What input does the company have to this process? The company has been formally advised by ERMA New Zealand that the ACNGT approval has been reviewed and that ERMA New Zealand is requesting Grounds for a Reassessment. If a Reassessment goes ahead, the company would be formally advised and would be able to make submissions if it is publicly notified. A non-notified Reassessment would not provide this opportunity but the company would be invited to comment. Under the Act, the decision may be appealed on points of law.
18. Would any aspect of the Reassessment be kept confidential? Applicants can ask to keep aspects of their application confidential for commercial reasons. However, this has to be weighed against the need for submitters and other parties to have sufficient information to take part in the process. The final decision is made by the Authority.
19. What is the final outcome? Under what circumstances could the old approval be revoked? The Committee may decide either that: · the existing approval and conditions are adequate to meet the requirements of the HSNO Act or · the conditions should be varied or · the approval is to be declined. If the approval was declined, the Authority may require the company to dispose of the organism at the company's expense. There would be no compensation payable in the event of this being required.
20. Who would be responsible for enforcing the decision? The Ministry of Agriculture and Forestry.
Ends
For further information contact:
Karen Cronin
Manager Communications.
Phone: 04 496 4826
Fax: 04 473 8433
or email to: info@ermanz.govt.nz