Applying to import a biological control agent into containment
- Preparing to make an application
- Pre-application consultation
- Identification and assessment of risks, costs and benefits
- Completing the application form
Preparing to make an application
Approval can be sought from the EPA to import a new organism into an approved containment facility in New Zealand rather than for general release. The differences in approach between these types of application are explored below, and advice is provided on preparing an application for importation into containment alone.
Importation into containment may be an appropriate course of action for a number of reasons. For example, in the course of gathering the information required to complete an application for full release of a biological control agent, an applicant may need to obtain data that can only be obtained in New Zealand. It may be necessary to complete experiments on the host range of the biological control agent in New Zealand because the test species are only present here.
Import of a new organism into New Zealand requires both a HSNO Act approval from the EPA and an Import Permit or Import Health Standard (IHS) from the Ministry for Primary Industries (MPI). If MPI have not already issued an import health standard for the organism then you will have to apply to MPI to have this standard developed. This can take longer than the HSNO Act approval from the EPA so it is worth talking to MPI early on in the process to ensure that you understand all of the regulatory requirements.
You can contact MPI at:
Ministry for Primary Industries
PO Box 2526
Phone: 0800 00 83 33
Fax: +64 4 894 0720
Email: [email protected]
Approved containment facilities
A containment facility is a place approved by the Ministry for Primary Industries (MPI) in accordance with the Biosecurity Act for holding organisms that should not (or not yet) become established in New Zealand. This is a facility constructed in accordance with a MPI construction standard to safely contain invertebrates [http://www.biosecurity.govt.nz/border/transitional-facilities/animals/154-02-08.htm] or microorganisms [http://www.biosecurity.govt.nz/border/transitional-facilities/animals/154-03-02.htm]. In addition to physical security, the facility must be operated according to a Quarantine and Containment Procedures that are negotiated and agreed with MPI Biosecurity. MPI staff regularly audit the quality assurance programme to ensure safe operation of containment facilities.
To reduce risks, the containment procedures contain a framework for developing contingency plans in the event of disease occurrence, inadvertent liberation (within and from the building), fire or any other emergency. It should describe the corrective action if there is an escape of organisms from containment. Action shall be immediately taken to prevent further escape and, if possible, to recover and return to containment the escaped organisms, or to eradicate an escaped population. In most cases however, at the point at which most biological control agents could be detected outside the building, it is likely that they exist at sufficient density, and have dispersed sufficiently that nothing could be done to mitigate the risk of establishment.
Once the EPA approves the release of a biological control agent, the applicant must then apply to MPI for a Permit to Import (contact MPI [mailto:[email protected]] for more information). Under section 39 of the Biosecurity Act, this permit will require the applicant to import the biological control agent into an approved Containment Facility for the purpose of quarantine to eliminate any associated organisms imported unintentionally with the culture. These include companion/passenger species, hyperparasites, parasitoids or detectable pathogens.
Considerations specific to a containment application
For applications to import a new organism for release, one of the main concerns for the EPA is the risk that the organism will form an unwanted population in New Zealand, that is, will naturalise to form a self-sustaining population that may have adverse effects on the environment, health and safety of people and communities.
In contrast, the assessment of risks associated with importation of a biological control agent into containment mainly hinge on the ability of the organism to escape from containment. In carrying out its consideration, the Authority will consider the adequacy of containment and the magnitude and likelihood of the risks, costs and benefits alongside each other and in an integrated fashion. In considering the ability of the organisms to escape from containment, the Authority takes account of the:
- biological characteristics of the organisms;
- containment regime; and
- potential pathways for escape of the organisms from the containment (e.g. structural failure, deliberate removal, disaster, etc),
The design and construction, together with the operating procedures, for an approved containment facility must ensure that the risks of escape to the environment is negligible. If this was not so, the containment facility would not be approved. However containment is not just about the physical structure and procedures it is also affected by the physical characteristics, biology and behaviour of the organisms which must also be taken into account. Although applicants must still assess the risks and costs that might ensue following escape from containment, in practice, the barrier imposed by containment makes the likelihood of environmental exposure to the imported organism highly improbable, and the overall risk will almost always be very low.
Because of this, the EPA often chooses to deal with containment applications without public notification via a non-notified pathway and in a relatively short timeframe. However, the EPA has the discretion to notify the application and call for public submissions if the level of public interest is expected to be high.
Refer to the EPA's non-notified application pathway flowchart [http://www.epa.govt.nz/Documents/is-flowchart-non-notified-applications-January%202011.pdf].
The written decision to approve the introduction of Aceria genistae [http://www.epa.govt.nz/search-databases/Pages/applications-details.aspx?appID=NOC05012#] into containment provides an example of how the EPA makes such a determination. A further example of a decision on an application (with controls) for containment is for the weevil Apion onopordi [http://www.epa.govt.nz/search-databases/Pages/applications-details.aspx?appID=NOC02004#], which was later considered for release for Californian thistle control. The controls included a condition that "the native puha and introduced puha are included in the first round of host plant testing."
Consultation is the continuous dialogue that takes place between an applicant and those interested in the application. The consultation process is discussed more fully on the next page, and the section entitled Background information on biological control safety, and more information can be found in the links listed below.
Given that approved containment facilities and their operating practices are licensed for containment, and are routinely audited, escape from such facilities can be considered 'highly improbable'. If this is so, the likelihood of exposure of the environment to possible adverse effects of the biological control agent is also highly improbable, and the overall risk is likely to be low, (except for organisms known to be potentially dangerous, but biological control agents already selected for high host-specificity are unlikely to fall into this category). The level of consultation before a containment application is prepared should be set by the need to discuss the characteristics of that low risk - the containment facility itself and its operating practices and how these relate to biological control agent biology. In practice, the acceptable level of community consultation for an import into containment application is low compared to that required for a release application (see following sections).
Consultation with the EPA
As with a release application, the applicant is advised to contact EPA staff [http://www.epa.govt.nz/Contact-us/Pages/Contact-us.aspx] early in the development of a project to canvas the level of consultation that might be required, to receive guidance whether the application will take the notified or non-notified decision path, and to finalise the timeframe. The EPA Maori Unit (Kaupapa Kura Taiao) will provide guidance on dialogue with the Maori organisation holding mana whenua in the area of the containment facility.
Applicants should consult the following resources available on the EPA website, and use these in conjunction with the information provided below.
- Determine if an organism is new [http://www.epa.govt.nz/new-organisms/find-application-form/all-applications/Pages/determine-if-new-application.aspx] and What is a new organism? [http://www.epa.govt.nz/new-organisms/about/Pages/what-is-a-no.aspx]
- The Application Finder [http://www.epa.govt.nz/new-organisms/find-application-form/application-finder/Pages/default.aspx]
to ascertain what type of application you want to make and to take you to the correct application form
Examples of applications to import into containment can be found on the EPA New Organisms Application Register. For example:
- Application to import Aceria genistae into containment [http://www.epa.govt.nz/search-databases/HSNO%20Application%20Register%20Documents/NOR05003.pdf]
Consultation with the Department of Conservation
Applicants are strongly advised to consult with the Department of Conservation about the application. Section 58 of the HSNO Act specifies that the Authority:
"Shall consult with all departments or Crown entities notified of the application in accordance with section 53 (4) of this Act and, where any application is for approval to import, develop, field test, or release a new organism, have particular regard to any submissions made by the Department of Conservation."
Consequently, DOC needs to advise the Authority so that possible impacts on New Zealand's conservation estate, native flora or fauna (directly or indirectly) which are likely to result from the introduction of a new organism are fully considered. A fuller discussion of DOC's role can be found in the section on preparation of an application for general or conditional release. Unless staff perceive a particular threat posed by the proposed biological control agent, DOC is unlikely to have major input into the consideration of a containment application. Nevertheless applicants are recommended to advise DOC of any impending application.
Department of Conservation
PO Box 10-420, 18-32 Manners Street
Email: [email protected]
Consultation with Iwi and Maori organisation
The HSNO Act requires the EPA to make informed decisions in relation to the interests of Maori, and it is the responsibility of the applicant to provide sufficient information to make that decision. This is discussed in detail in more detail in the section on preparation of an application for general or conditional release. A proposal to import a new organism into containment has significant impact only in the rohe (iwi district) [http://en.wikipedia.org/wiki/Rohe] where the containment facility is located. Formally consult with the hapu or iwi that exercises mana whenua over that region, according to EPA guidelines. It is likely that the facility operator already has an ongoing relationship with local hapu and iwi, and can provide guidance on who to contact. Ensure that concerns and questions raised during consultation are followed up appropriately, documented, and included in the application, along with a description of the consultation process.
Consultation with other organisations
Applicants may wish to identify other organisations or stakeholders to inform of their intention to apply for the introduction of a biological control agent into containment. As with consultation with Maori, consultation can be limited to individuals or organisations local to the containment facility. However if you intend to eventually release the organisms then it may be worth identifying organisation with a broader interest and consulting more widely.
Identification and assessment of risks, costs and benefits
A risk, cost, benefit analysis forms the core of the information upon which the Authority will decide whether or not to approve an application for importation of a control agent into containment. The applicant must provide sufficient information to enable the Authority to make that decision. The identification and assessment of risks, costs and benefits is approached in the same way whether the application is for containment or for general release. The likelihood of environmental, human health, social, cultural or economic effects (whether adverse or beneficial) arising from the introduction of an organism into containment will be relatively low in almost all cases.
Risks and costs
All foreseeable and reasonable effects of the proposal to import the organism into containment must be identified systematically to ensure that nothing is left unconsidered. In particular, the applicant must address the possible pathways by which an organism might escape containment. The applicant should explain how risk identification was conducted, and explain the basis on which some risks were eliminated as insignificant. The magnitude and likelihood of each risk should be assessed.
See technical guides mentioned above.
Benefits and cost-benefit analysis
As with risks and costs, the magnitude of benefits is a function of the magnitude of the benefits and the likelihood that those benefits will be achieved. The primary benefits of a proposal to import only into containment are the acquisition of essential knowledge to support an application to release, or the elimination of associated organisms prior to release and not the ultimate benefits of the eventual biological control programme.
The applicant should present a contingency plan that outlines the response to escape of the organism in any part of the facility, and how this would mitigate risk (refer to section Completing an application to the EPA for the introduction into containment of a biological control agent').
Completing the application form
Here you will find information and helpful links to assist you to complete the EPA application form for the introduction into containment of a new organism for use as a biological control agent.
If you wish to complete an application to import a biological control agent for general release instead, advice on completing that form can be found in the relevant section.
Contact with the EPA
Once a control agent has been selected for introduction, applicants are strongly advised to contact [http://www.epa.govt.nz/Contact-us/Pages/Contact-us.aspx] and enter into a dialogue with EPA staff to discuss the likely timeframe, the appropriate level and style of consultation, and the type and breadth of data that will be required for an application.
An open and transparent consultation process is likely to expedite the consideration of an application. Most applications to the EPA for introduction of an biological control agent into containment will not be notified, and applicants will not need to consult widely. The EPA will advise on the appropriate level of consultation.
The iwi or hapu with mana whenua over the area in which the containment facility is situated should be consulted. Effective consultation before and during the application process is likely to reduce the level of opposition to the application, or if not, it will better inform the process, including consultation with Maori.
Word and pdf [http://www.epa.govt.nz/new-organisms/find-application-form/all-applications/Pages/import-no-application.aspx] versions of the form are available for seeking approval to import into containment any new organism. Bear in mind that the form is used for all new organism applications, not just biological control agents.
To obtain approval for new organisms in containment [http://www.epa.govt.nz/Publications/Application_Form_Containment_EPA0324_(PdfVersion).pdf]. There are 10 sections to this form:
Section 1This section requires contact information regarding the applicant.
Section 2This section requires information about the type of new organism and the type of containent activity that is proposed. Section 2.2 requires a short statement to explain what the application is about. For example: "It is proposed that species A is introduced into containment so that its efficacy and biosafety can be investigated for biological control of species B." Section 2.3 requires a a non-technical summary of the application and reasons for it. In Section 2.4 a longer explanation of the application is needed which requests information about the wider context of the application, for example, what the longer-term expectations are for the new organism(s) which is/are the subject of the application. In the context of biological control it would be expected that the applicant would give some background to the application and explain the pest problem that studies in containment seek to address. So for example, it could be explained that while in containment, host range testing and risk assessments will be carried out to investigate the suitability of the organism for a biological control release, and to determine whether there are any associated organisms that could pose a risk to non-target organism or the New Zealand biota.
Section 3In this section the taxonomic details of the organism(s) need to be entered. It is really important that there is no confusion or ambivalence about the organism's identity. Assuming the proposed biological control agent is not a GMO, the full taxonomic identity of the organism should be given, from phylum, class, order, family, subfamily,tribe down to species/subspecies, with the name of the author of the species name, and if possible, the date for the species description. For example Genus species author, date. If the author's name is in brackets it means that the species was originally described in a different genus, so it important to be accurate. It can also help if synonyms are listed (earlier names given to this species). Any known biotypes or ecotypes of the organism should be discussed, especially if they are likely to have a different host range.
Information on the biology and "main features" of the organism is requested in this section, for example: its known host range; what it feeds on; its phenology and stages of the life cycle; any known natural enemies; known host records; previous use as a biological conrol agent; its geographical and climatic range; dispersal ability etc. Details of any inseparable organisms such as endosymbionts should be given if this knowledge is available.
The form asks whether the organism has affinities with other organisms in New Zealand. So here the EPA will want to find out about taxonomically related species present in New Zealand as well as organisms which occur in the environment in which the proposed biological control agent is intended to be released (ecological affinities). Clearly information on species that could be at risk from the introduction because of their 'relatedness' should be given here, or an account of the taxonomic distance of the proposed organism and the New Zealand fauna.
The last two questions in Section 3 request information on the likelihood that the organism could form a self-sustaining population. So in the context of an application for introduction to containment, the EPA will want to know whether, if it did escape from containment, it could easily establish and rapidly spread, or if not, what the limiting factors to this would be. It is also asked here, in the context of escape from containment, whether eradication would be possible, and under what circumstances this could be assured (or not). Reference to containment facility protocols required under the Biosecurity Act could be made here.
Section 4Section 4.1 is unlikely to be applicable for biological control agents because it would rarely be possible in New Zealand to carry out field tests. If this is the intention, the applicant should discuss this in detail with EPA advisors. Section 4.2 asks for details of the containment facility and measures that will be in place to preclude the possibility of escape of the organism. The EPA will want to know details of how the organism will be transported to the facility, whether it will be moved between buildings and how it will be contained. Again details of MPI approvals, record-keeping, safety protocols, and audits of the facility should be quoted here. A contingency plan in place in the event of escape of the organism in question should be documented.
Section 5This section asks for details of Maori engagement that has taken place in relation to this application. The outcome from the consultation should be given here. See Consultation with Maori and the links given to EPA resources in that section.
Section 6This is one of the most important sections of the application form. Although this is an application to import a biological control agent into containment, the EPA will want to know what the longer term plans of the applicant are with respect to this organism. So if it is anticipated that the organism will become the subject of an application for release for biological control, it will be necessary to explain the risks and benefits of the release, assuming that the results of the containment studies are positive. It would be useful to discuss studies that have taken place in the native range of the organism; whether it has been used elsewhere for biological control and if so, what was its efficacy against the target pest and what is known about its biosafety; have any other organisms been used in New Zealand for this pest, and what is the predicted compatibility with the proposed organism and other existing IPM measures, and why a further biocontrol introduction is necessary. In addition, information on discussions held with stakeholders and support/opposition to the programme would be useful.
Sections 7 and 8These sections are not relevant to biological control.
Section 9This section is included for any other information that has not been covered elsewhere in the form that the EPA needs to be aware of.
Consultation with the EPA before making the application is very strongly advised and it expected that discussions would have taken place with EPA staff well before getting to the stage of submitting a formal application. EPA staff are very happy to assist applicants with any aspect of completing the form.
Selecting biological control agents