Applying for general release or release with controls
Release with Controls
The HSNO Act was amended in 2003 to include an option for applicants, where appropriate, to apply for conditional release, or release with controls. If such an approval is given, then the release is subject to controls which are intended to manage risk.
If an applicant is using previous applications as a guideline, be aware that until 2003 applicants could only choose to apply for fully contained approvals (including field trials) or full (unconditional) releases with no controls. The release with controls approvals are intended to fill the gap between containment and full (unconditional) release approvals by allowing controls to be imposed on how new organisms are used.
An applicant may wish to seek a release with controls for a variety of reasons. If the applicant chooses to propose controls in a release with controls application for a new organism, the HSNO Committee can then impose any type of controls it considers appropriate to manage risks (see section 38D). In making its decision the HSNO Committee will take account of the controls it intends to impose in deciding whether the organism:
- meets the minimum standards set out in Section 36 of the HSNO Act and the matters that need to be taken into account including the ability of the organism to establish self-sustaining populations, and ease of eradication (Section 38C(2))
- as with other determinations, after taking all these factors into account, the HSNO Committee will decide whether the positive effects of the organism (and any inseparable organism) outweigh the adverse effects. If they do, the application will be approved with controls, as set out in Section 38A of the HSNO Act [http://www.legislation.govt.nz/act/public/1996/0030/latest/DLM383535.html].
The duration of the controls for a conditional release [http://www.legislation.govt.nz/act/public/1996/0030/latest/DLM383543.html] may be finite, if the HSNO Committee considers that an expiry date is warranted. Alternatively, if considered appropriate, an approval can be set in perpetuity. If the conditional release approval is set to expire, which is unlikely for a biological control agent, depending on the control it must be possible to recovery or destroy the organisms. In this case the HSNO Committee will set conditions that ensure that all new organisms for which a release with controls approval has been granted can be identified and located at the time of expiry. This will include heritable material viable at the expiry of an approval. If the EPA cannot be assured that all organisms can be located, then no approval will be given.
In the case of a release with controls, the organism remains a "new organism" when all controls have expired, and a new HSNO approval would be needed for its continued use. However, it is possible to set controls 'in perpetuity'.
Benefits and cost-benefit analysis
Completing the application forms