Applying for general release or release with controls

Preparing to make an application

The following guidance is given for the development and preparation of an application to the EPA to import for release, or release from containment, or release with controls predators, parasitoids, herbivores or pathogens for the purpose of biological control of a plant, animal or disease. This advice does not apply to genetically modified new organisms, or to introduction of a new organism under emergency, or to the introduction of any material for medical or veterinary purposes.

In the course of introducing a new biological control agent, the applicant may need to import the organism into containment for further evaluation of efficacy of the biological control agent, and host range specificity testing.

In order to determine whether the organism proposed for introduction is indeed a new organism, applicants should refer to the EPA web page . It is also possible to submit an application to or not.

The steps in the process of applying for approval to introduce a new biological control agent for general release (with and without controls) are as follows:

Selection of the biological control agent
Pre-application consultation with
- EPA staff
- DOC
- MPI
- Maori
- Other stakeholders and interest groups
Preparation for an application
Identification and assessment of risks and benefits
Formal receipt of application
Post-application processes
Public submissions on the application
Staff assessment report (report prepared by the EPA)
Public hearing (if required) before the Authority
Consideration by decision-making committee
Decision
Notification of Decision

As much as the content of the proposal is important, it is the quality of the process by which the application is prepared that will give the EPA confidence that the applicant has addressed all relevant factors. Gaining that confidence is likely to reduce statutory delays and ensure the rapid evaluation of the proposal. For that reason, it is important for applicants to be thorough, frank, open and inclusive when assembling the information that EPA requires. The first step in preparing an application should be to contact an EPA New Organisms Advisor [http://www.epa.govt.nz/Contact-us/Pages/Contact-us.aspx] and develop a dialogue.

For most applications to import a new organism the primary concern is the risk that the organism will form an unwanted population in New Zealand, that will have adverse environmental effects.

Clause 33 of the Methodology states:

"When considering an application, the Authority must have regard to the extent to which the following risk characteristics exist:
(a) Exposure to risk is involuntary
(b) The risk will persist overtime
(c) The risk is subject to uncontrollable spread and is likely to extend its effects beyond the immediate location of incidence
(d) The potential adverse effects are irreversible
(e) The risk is not known or understood by the general public and there is little experience or understanding of possible means of managing the potential adverse effects."

In accordance with clause 33 of the Methodology, the Authority is likely to be more cautious and risk averse according to the extent to which these risk characteristics exist.

New organisms released as biological control agents will usually exhibit all of these characteristics because that is what the applicant intends. To become successful, the agent must establish, populations must be self-sustaining, and biological control agents must spread to attack the host in its entire range. In considering risks for biological control agents, the EPA have to balance the acceptable characteristics intended for a beneficial biological control outcome with those risks which relate to unintended outcomes.